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The Bone & Joint Journal
Vol. 106-B, Issue 5 | Pages 435 - 441
1 May 2024
Angelomenos V Mohaddes M Kärrholm J Malchau H Shareghi B Itayem R

Aims

Refobacin Bone Cement R and Palacos R + G bone cement were introduced to replace the original cement Refobacin Palacos R in 2005. Both cements were assumed to behave in a biomechanically similar fashion to the original cement. The primary aim of this study was to compare the migration of a polished triple-tapered femoral stem fixed with either Refobacin Bone Cement R or Palacos R + G bone cement. Repeated radiostereometric analysis was used to measure migration of the femoral head centre. The secondary aims were evaluation of cement mantle, stem positioning, and patient-reported outcome measures.

Methods

Overall, 75 patients were included in the study and 71 were available at two years postoperatively. Prior to surgery, they were randomized to one of the three combinations studied: Palacos cement with use of the Optivac mixing system, Refobacin with use of the Optivac system, and Refobacin with use of the Optipac system. Cemented MS30 stems and cemented Exceed acetabular components were used in all hips. Postoperative radiographs were used to assess the quality of the cement mantle according to Barrack et al, and the position and migration of the femoral stem. Harris Hip Score, Oxford Hip Score, Forgotten Joint Score, and University of California, Los Angeles Activity Scale were collected.


The Bone & Joint Journal
Vol. 106-B, Issue 3 Supple A | Pages 31 - 37
1 Mar 2024
Bunyoz KI Tsikandylakis G Mortensen K Gromov K Mohaddes M Malchau H Troelsen A

Aims

In metal-on-polyethylene (MoP) total hip arthroplasty (THA), large metal femoral heads have been used to increase stability and reduce the risk of dislocation. The increased size of the femoral head can, however, lead to increased taper corrosion, with the release of metal ions and adverse reactions. The aim of this study was to investigate the relationship between the size of the femoral head and the levels of metal ions in the blood in these patients.

Methods

A total of 96 patients were enrolled at two centres and randomized to undergo MoP THA using either a 32 mm metal head or a femoral head of between 36 mm and 44 mm in size, being the largest possible to fit the thinnest available polyethylene insert. The levels of metal ions and patient-reported outcome measures (Oxford Hip Score, University of California, Los Angeles Activity Scale) were recorded at two and five years postoperatively.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_12 | Pages 34 - 34
23 Jun 2023
Bunyoz KI Tsikandylakis G Mortensen K Gromov K Mohaddes M Malchau H Troelsen A
Full Access

In metal-on-polyethylene (MoP) THA large femoral metal heads are designed to increase stability and to reduce dislocation risk. The increased head size could lead to increased taper corrosion with the release of metal ions and adverse reactions. Using blood ion measurements, we aimed to investigate the association between femoral head size and metal-ion release after MoP THA.

96 patients were enrolled at two centers and randomized to receive either a 32-mm metal head or a 36–44 mm metal head (the largest possible fitting the thinnest available polyethylene insert). Blood metal ions and PROMs (OHS, UCLA) were measured at two- and five-year follow-ups.

Both 2- and 5-year median chrome, cobalt, and titanium levels were below taper corrosion indicative ion levels. At 5 years, median chrome, cobalt, and titanium levels were 0.5 μg/L (0.50–0.62), 0.24 μg/L (0.18–0.30), and 1.16 μg/L (1.0–1.68) for the 32-mm group, and 0.5 μg/L (0.5–0.54), 0.23 μg/L (0.17–0.39), and 1.30 μg/L (1–2.05) for the 36–44 mm group, with no difference between groups (p=0.825, p=1.000, p=0.558). At 2 years, 7 (32-mm) versus 4 (36–44-mm) patients had elevated ions. At 5 years, 6 (32-mm) versus 7 (36–44-mm) patients had elevated ions. There was no difference in either OHS (p=0.665) or UCLA (p=0.831) between patients with or without elevated blood metal ions.

5 years after the insertion of MoP THAs, we found no differences in the blood metal ion levels between 32 mm heads and 36–44 mm heads and no corrosion-related revisions. As taper corrosion can debut after 5 years, there is still a need for long-term follow-up studies on the association between head size and corrosion in MoP THA.


The Bone & Joint Journal
Vol. 104-B, Issue 7 | Pages 765 - 766
1 Jul 2022
Haddad FS Malchau H


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_14 | Pages 36 - 36
1 Nov 2021
Malchau KS Tillander J Zaborowska M Hoffman M Lasa I Thomsen P Malchau H Rolfson O Trobos M
Full Access

Periprosthetic joint infections (PJI) are challenging complications following arthroplasty. Staphylococci are a frequent cause of PJI and known biofilm producers.

Reoperations for PJI of the hip or knee between 2012 and 2015 performed at Sahlgrenska University Hospital were identified. Medical records were reviewed, and clinical parameters recorded for patients whose intraoperative bacterial isolates had been stored at the clinical laboratory. Staphylococcal strains isolated from reoperations due to first-time PJI were characterised by their ability to form biofilms using the microtiter plate test.

The study group included 49 patients (70 bacterial strains) from first-time PJI, whereof 24 (49%) patients had recurrent infection. Strong biofilm production was significantly associated with recurrent infection. Patients infected with strong biofilm producers had a five-fold increased risk for recurrent infection.

Strong biofilm production was significantly associated with increased antimicrobial resistance and PJI recurrence. This underscores the importance of determining biofilm production and susceptibility as part of routine diagnostics in PJI. Strong staphylococcal biofilm production may have implications on therapeutic choices and suggest more extensive surgery. Furthermore, despite the increased biofilm resistance to rifampicin, results from this study support its use in staphylococcal PJI.


The Bone & Joint Journal
Vol. 103-B, Issue 7 | Pages 1206 - 1214
1 Jul 2021
Tsikandylakis G Mortensen KRL Gromov K Mohaddes M Malchau H Troelsen A

Aims

We aimed to investigate if the use of the largest possible cobalt-chromium head articulating with polyethylene acetabular inserts would increase the in vivo wear rate in total hip arthroplasty.

Methods

In a single-blinded randomized controlled trial, 96 patients (43 females), at a median age of 63 years (interquartile range (IQR) 57 to 69), were allocated to receive either the largest possible modular femoral head (36 mm to 44 mm) in the thinnest possible insert or a standard 32 mm head. All patients received a vitamin E-doped cross-linked polyethylene insert and a cobalt-chromium head. The primary outcome was proximal head penetration measured with radiostereometric analysis (RSA) at two years. Secondary outcomes were volumetric wear, periacetabular radiolucencies, and patient-reported outcomes.


The Bone & Joint Journal
Vol. 102-B, Issue 10 | Pages 1303 - 1310
3 Oct 2020
Kjærgaard K Ding M Jensen C Bragdon C Malchau H Andreasen CM Ovesen O Hofbauer C Overgaard S

Aims

The most frequent indication for revision surgery in total hip arthroplasty (THA) is aseptic loosening. Aseptic loosening is associated with polyethylene liner wear, and wear may be reduced by using vitamin E-doped liners. The primary objective of this study was to compare proximal femoral head penetration into the liner between a) two cross-linked polyethylene (XLPE) liners (vitamin E-doped (vE-PE)) versus standard XLPE liners, and b) two modular femoral head diameters (32 mm and 36 mm).

Methods

Patients scheduled for a THA were randomized to receive a vE-PE or XLPE liner with a 32 mm or 36 mm metal head (four intervention groups in a 2 × 2 factorial design). Head penetration and acetabular component migration were measured using radiostereometric analysis at baseline, three, 12, 24, and 60 months postoperatively. The Harris Hip Score, University of California, Los Angeles (UCLA) Activity Score, EuroQol five-dimension questionnaire (EQ-5D), and 36-Item Short-Form Health Survey questionnaire (SF-36) were assessed at baseline, three, 12, 36, and 60 months.


The Bone & Joint Journal
Vol. 102-B, Issue 7 Supple B | Pages 90 - 98
1 Jul 2020
Florissi I Galea VP Sauder N Colon Iban Y Heng M Ahmed FK Malchau H Bragdon CR

Aims

The primary aim of this paper was to outline the processes involved in building the Partners Arthroplasty Registry (PAR), established in April 2016 to capture baseline and outcome data for patients undergoing arthroplasty in a regional healthcare system. A secondary aim was to determine the quality of PAR’s data. A tertiary aim was to report preliminary findings from the registry and contributions to quality improvement initiatives and research up to March 2019.

Methods

Structured Query Language was used to obtain data relating to patients who underwent total hip or knee arthroplasty (THA and TKA) from the hospital network’s electronic medical record (EMR) system to be included in the PAR. Data were stored in a secure database and visualized in dashboards. Quality assurance of PAR data was performed by review of the medical records. Capture rate was determined by comparing two months of PAR data with operating room schedules. Linear and binary logistic regression models were constructed to determine if length of stay (LOS), discharge to a care home, and readmission rates improved between 2016 and 2019.


The Bone & Joint Journal
Vol. 102-B, Issue 6 | Pages 736 - 743
1 Jun 2020
Svensson K Rolfson O Mohaddes M Malchau H Erichsen Andersson A

Aims

To investigate the experience and emotional impact of prosthetic joint infection (PJI) on orthopaedic surgeons and identify holistic strategies to improve the management of PJI and protect surgeons’ wellbeing.

Methods

In total, 18 prosthetic joint surgeons in Sweden were recruited using a purposive sampling strategy. Content analysis was performed on transcripts of individual in-person interviews conducted between December 2017 and February 2018.


The Bone & Joint Journal
Vol. 102-B, Issue 1 | Pages 55 - 63
1 Jan 2020
Hagberg K Ghassemi Jahani S Kulbacka-Ortiz K Thomsen P Malchau H Reinholdt C

Aims

The aim of this study was to describe implant and patient-reported outcome in patients with a unilateral transfemoral amputation (TFA) treated with a bone-anchored, transcutaneous prosthesis.

Methods

In this cohort study, all patients with a unilateral TFA treated with the Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA) implant system in Sahlgrenska University Hospital, Gothenburg, Sweden, between January 1999 and December 2017 were included. The cohort comprised 111 patients (78 male (70%)), with a mean age 45 years (17 to 70). The main reason for amputation was trauma in 75 (68%) and tumours in 23 (21%). Patients answered the Questionnaire for Persons with Transfemoral Amputation (Q-TFA) before treatment and at two, five, seven, ten, and 15 years’ follow-up. A prosthetic activity grade was assigned to each patient at each timepoint. All mechanical complications, defined as fracture, bending, or wear to any part of the implant system resulting in removal or change, were recorded.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_12 | Pages 24 - 24
1 Oct 2019
Florissi IS Galea VP Rojanasopondist P Sauder N Iban YEC Malchau H Bragdon CR
Full Access

Introduction

This analysis aims to provide an update of the Level-IV Partners Arthroplasty Registry (PAR), a quality-improvement initiative and research data repository.

Methods

The Harris Joint Registry was founded in 1969 and has since expanded to become the Partners Arthroplasty Registry (PAR). Today, the PAR captures data on total hip and total knee arthroplasties conducted at seven hospitals in Massachusetts. Over time, data has been sourced through independent collection at a single hospital, retrospective sourcing through the Research Patient Data Registry (RPDR), and currently through the Enterprise Data Warehouse (EDW). Various statistical methods analyzed changing trends of care provided to patients across affiliated institutions. PROMs collected in the PAR are the PROMIS Physical Function and Global Health Short Forms, the HOOS and KOOS. The registry is an associate member of ISAR and will incorporate the international implant library.


The Bone & Joint Journal
Vol. 101-B, Issue 7 | Pages 758 - 759
1 Jul 2019
Galea VP Rojanasopondist P Laursen M Muratoglu OK Malchau H Bragdon C


The Bone & Joint Journal
Vol. 101-B, Issue 7 | Pages 760 - 767
1 Jul 2019
Galea VP Rojanasopondist P Laursen M Muratoglu OK Malchau H Bragdon C

Aims

Vitamin E-diffused, highly crosslinked polyethylene (VEPE) and porous titanium-coated (PTC) shells were introduced in total hip arthroplasty (THA) to reduce the risk of aseptic loosening. The purpose of this study was: 1) to compare the wear properties of VEPE to moderately crosslinked polyethylene; 2) to assess the stability of PTC shells; and 3) to report their clinical outcomes at seven years.

Patients and Methods

A total of 89 patients were enrolled into a prospective study. All patients received a PTC shell and were randomized to receive a VEPE liner (n = 44) or a moderately crosslinked polyethylene (ModXLPE) liner (n = 45). Radiostereometric analysis (RSA) was used to measure polyethylene wear and component migration. Differences in wear were assessed while adjusting for body mass index, activity level, acetabular inclination, anteversion, and head size. Plain radiographs were assessed for radiolucency and patient-reported outcome measures (PROMs) were administered at each follow-up.


The Bone & Joint Journal
Vol. 101-B, Issue 7 | Pages 768 - 778
1 Jul 2019
Galea VP Rojanasopondist P Ingelsrud LH Rubash HE Bragdon C Huddleston III JI Malchau H Troelsen A

Aims

The primary aim of this study was to quantify the improvement in patient-reported outcome measures (PROMs) following total hip arthroplasty (THA), as well as the extent of any deterioration through the seven-year follow-up. The secondary aim was to identify predictors of PROM improvement and deterioration.

Patients and Methods

A total of 976 patients were enrolled into a prospective, international, multicentre study. Patients completed a battery of PROMs prior to THA, at three months post-THA, and at one, three, five, and seven-years post-THA. The Harris Hip Score (HHS), the 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS), the SF-36 Mental Component Summary (MCS), and the EuroQol five-dimension three-level (EQ-5D) index were the primary outcomes. Longitudinal changes in each PROM were investigated by piece-wise linear mixed effects models. Clinically significant deterioration was defined for each patient as a decrease of one half of a standard deviation (group baseline).


The Bone & Joint Journal
Vol. 100-B, Issue 12 | Pages 1592 - 1599
1 Dec 2018
Galea VP Connelly JW Shareghi B Kärrholm J Sköldenberg O Salemyr M Laursen MB Muratoglu O Bragdon C Malchau H

Aims

The primary aim of this study was to compare the wear properties of vitamin E-diffused, highly crosslinked polyethylene (VEPE) and one formulation of moderately crosslinked and mechanically annealed ultra-high molecular weight polyethylene (ModXLPE) in patients five years after primary total hip arthroplasty (THA). The secondary aim was to assess the clinical results of patients treated with VEPE by evaluating patient-reported outcome measures (PROMs), radiological evidence of fixation, and the incidence of mechanical failure.

Patients and Methods

A total of 208 patients (221 THAs) from four international centres were recruited into a prospective study involving radiostereometric analysis (RSA) and the assessment of clinical outcomes. A total of 193 hips (87%) were reviewed at the five-year follow-up. Of these, 136 (70%) received VEPE (vs ModXLPE) liners and 68 (35%) received ceramic (vs metal) femoral heads. PROMs and radiographs were collected preoperatively and at one, two, and five years postoperatively. In addition, RSA images were collected to measure PE wear postoperatively and at one, two, and five years after surgery.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_12 | Pages 20 - 20
1 Oct 2018
Galea V Connelly J Matuszak S Botros MA Rojanasopondist P Nielsen C Huddleston J Bragdon C Malchau H Troelsen A
Full Access

Introduction

The aim of this study was to evaluate the effects of posterior tibial slope (PTS) and posterior condylar offset (PCO) on patient-reported pain and function one year after TKA.

Methods

A total of 500 patients from 11 clinics in 6 countries were enrolled into a prospective, multicenter study. All patients were indicated for primary TKA for OA and received components from a single manufacturer. All liners were made from vitamin-E stabilized, highly crosslinked (95 kGy) polyethylene; 54.7% were posterior stabilized (PS) and the remaining were cruciate-retaining.

The Knee Injury and Osteoarthritis Outcome Score (KOOS) was administered at the one-year follow-up visit. The KOOS pain and activities in daily life (ADL) sub-scores were dichotomized and served as the primary outcomes. Dichotomization was done with the patient acceptable symptom state (PASS), defined by previous studies as the value of the PROM above which patients deem their state as acceptable (84.5 points for KOOS pain and 83.0 points for KOOS ADL).

Plain lateral radiographs were taken and assessed for PTS (Figure 1) and PCO (Figure 2). PTS was categorized as above (excessive flexion), within (ideal), or below (extension) the safe zone of 0° − 7° of flexion. PCO increases or decreases of greater than 3mm were compared against no change (≤ 3mm). Each of the two sagittal positioning metrics was tested against the KOOS pain and ADL PASS at one year.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_13 | Pages 48 - 48
1 Oct 2018
Galea VP Connelly JW Matuszak SJ Rojanasopondist P Bragdon CR Huddleston JI Rubash HE Malchau H
Full Access

Introduction

Within the field of arthroplasty, the use of patient-reported outcome measures (PROMs) is becoming increasingly ubiquitous in an effort to employ more patient-centered methods of evaluating success. PROMs may be used to assess general health, joint-specific pain or function, or mental health. General and joint-specific questionnaires are most often used in arthroplasty research, but the relationship between arthroplasty and mental health is less well understood. Furthermore, longitudinal reports of PROM changes after arthroplasty are lacking in the literature.

Our primary aim was to quantify the improvement in general, joint-specific, and mental health PROMs following total hip arthroplasty (THA) as well as the extent of any deterioration through the 7 years follow-up. Our secondary aim was to identify predictors of clinically significant PROM decline.

Methods

A total of 864 patients from 17 centers across 8 countries were enrolled into a prospective study. Patients were treated with components from a single manufacturer, which have been shown to be well-functioning in other studies.

Patients completed a battery of PROMs preoperatively, and at one, three, five, and seven years post-THA. Changes in PROMs between study visits were assessed via paired tests.

Postoperative trends for each PROM were determined for each subject by the slope of the best-fit line of the four postoperative data points. Significant PROM deterioration was defined as one literature-defined minimum clinically important difference over 5-years. Binary logistic regressions were used to identify independent predictors of significant decline in the EuroQol (EQ-5D) visual analogue scale (VAS) for Health State, 36-Item Short Form Survey (SF-36) physical composite summary (PCS), and SF-36 mental composite summary (MCS).


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_13 | Pages 46 - 46
1 Oct 2018
Matuszak SJ Galea VP Rojanasopondist P Connelly JW Bragdon CR Huddleston JI Malchau H
Full Access

Introduction

The goal of the current study was to determine if SES affects PROMs in patients treated with THA. Specifically, we sought to determine any potential differences between low and high SES patients in pre-surgical PROMs, post-surgical PROMs, and PROM improvement after surgery while controlling for any potential confounding demographic factors.

Methods

Patients were selected from a clinical registry at an urban tertiary academic medical center. All patients undergoing primary THA between January 1, 2000 and April 1, 2016 were eligible for this study. During this period, patients were asked to complete the Harris Hip Score (HHS), Euro-QoL 5 Dimension (EQ-5D), 0–10 Numerical Rating Scale (NRS) Pain, 0–10 NRS Satisfaction (only given postoperatively), the Charnley Classifier, and the University of California Los Angeles (UCLA) Activity Score.

To determine SES, patients were matched by zip code to corresponding median household income as reported by the United States Census Bureau. Patients were then dichotomized into low and high SES groups using 2016 median household income of $57,617 USD as a cutoff point.

Statistical differences between low and high SES patients were determined for demographic factors, preoperative PROMs, postoperative PROMs, and PROM change. Non-parametric variables were tested with the Mann Whitney U test and categorical variables were tested with the Chi squared test.

Multivariate models were created to determine if SES group was independently predictive of achieving a minimal clinically important improvement (MCII) in PROMs (18.0 for HHS, −2.0 for NRS Pain, and 0.92 for UCLA). As potential confounders, we tested body mass index (BMI), preoperative health state from EQ-5D visual analog scale (EQ VAS), age at surgery, preoperative Charnley class, sex, and time between PROMs.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_13 | Pages 47 - 47
1 Oct 2018
Rojanasopondist P Galea VP Connelly JW Matuszak SJ Bragdon CR Rolfson O Malchau H
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Introduction

As orthopaedics shifts towards value-based models of care, methods of evaluating the value of procedures such as a total hip arthroplasty (THA) will become crucial. Patient reported outcome measures (PROMs) can offer a meaningful way for patient-centered input to factor into the determination of value.

Despite their benefits, PROMs can be difficult to interpret as statistically significant, but not clinically relevant, differences between groups can be found. One method of correcting this issue is by using a minimal clinically important improvement (MCII), defined as the smallest improvement in a PROM determined to be important to patients.

This study aims to find demographic and surgical factors that are independently predictive of failing to achieve a MCII in pain and physical function at 1-year following THA.

Methods

A total of 976 patients were enrolled into a prospective international, multicenter study evaluating the long-term clinical performance of two acetabular shells and two polyethylene liners from a single manufacturer. All patients consented to be followed with plain radiographs and a set of PROMs preoperatively and at 1-year after surgery.

The outcomes considered in this study were achieving literature-defined MCIIs in pain and physical function at one year after THA. The MCII in pain was defined as achieving a 2-point decrease on the Numerical Rating Scale (NRS)-Pain or reporting a 1-year NRS-Pain value of 0, indicating no pain. The MCII in physical function was defined as achieving an 8.29-point increase on the SF-36 Physical Function subscore.

Univariate analyses were conducted to determine if there were statistically significant differences between patients who did achieve and did not achieve a MCII. Variables tested included: demographic and surgical factors, general and mental health state, and preoperative radiographic findings such as deformity and joint space width (JSW). Significant variables were entered into a multivariable binary logistic regression.

Receiver-operating characteristic (ROC) analysis was used to generate cutoff values for significant continuous variables. Youden's index was used to identify cutoff points that maximized both specificity and sensitivity.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_11 | Pages 36 - 36
1 Aug 2018
Muratoglu O Galea V Connelly J Shareghi B Kärrholm J Sköldenberg O Salemyr M Laursen M Bragdon C Malchau H
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The primary purpose of the current study was to evaluate and compare the wear properties of vitamin E-doped, highly-crosslinked PE (VEPE) and one formulation of moderately cross-linked and mechanically-annealed ultra-high molecular weight PE (ModXLPE) in patients five years after primary THA. We also sought to understand whether polyethylene wear is associated with radiographic evidence of bone resorption or with deterioration in patient-reported outcome measures (PROMs).

A total of 221 patients from four international centers were recruited into a prospective RSA and clinical outcomes study. Seventy percent (76%) of patients received VEPE (vs. ModXLPE) liners, and 36% received ceramic (vs. metal) femoral heads. PROMs and radiographs were collected preoperatively and at one, two, and five years postoperatively. In addition, RSA radiographs were collected to measure PE wear.

We observed similar bedding in through the one-year interval and wear through the two-year interval between the two liner types. However, there was significantly more femoral head penetration in the ModXLPE cohort compared to the VEPE cohort at the five-year follow-up (p<0.001). The only variables independently predictive of increased wear were ModXLPE (vs VEPE) liner type (β=0.22, p=0.010) and metal (vs. ceramic) femoral head type (β=0.21, p=0.013). There was no association between increased wear and radiolucency development (p=0.866) or PROMs. No patients were found to have evidence of osteolysis.

At five-years postoperatively, patients treated with VEPE (vs. ModXLPE) and ceramic (vs. metal) femoral heads demonstrated decreased wear. At the longest follow-up (five years postoperatively), the wear rates for both liner groups were very low and have not led to any osteolysis or implant failures via aseptic loosening.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_11 | Pages 15 - 15
1 Aug 2018
Rolfson O Mohaddes M Rogmark C Kärrholm J Malchau H
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The Swedish Hip Arthroplasty Register started in 1979 and celebrates its 40th anniversary in 2019. The Swedish Hip Arthroplasty Register is not primarily a device register or research database; we strive to provide an overall assessment of the care provided with a multidimensional approach, and to disseminate knowledge on best practices in our network of participating hospitals. Since the inception of the register, there has been a marked change in trends and outcomes.

The completeness of registrations has been 97–99% for primary THA, 93–95% for revisions, and 95–98% for HA over the last 10 years. The register contains 371,125 primary THAs, 55,893 HAs, 83,233 reoperations, and 408,110 PROM responses registered in 352,585 unique patients. All outcome measures have improved over time; primary THA has 0.71% 90-day mortality, 94.3% 10-year implant survival, and 2.2% 2-year reoperation rate. At 1-year follow up, 91% of the patients report a clinically significant pain reduction, 76% report a substantial improvement in health-related quality of life, and 89% are satisfied with the result of the operation.

Moving forward, we are developing enhanced online applications for surgeons, patients and the implant industry to access real-time information. This work involves constructing a shared decision-making tool that helps clinicians assessing the future benefits and risks of THA by offering individualized outcome predictions. Further steps forward include randomized clinical trials and nested studies through the registry's platform. The trends and changes in Swedish arthroplasty practice have largely been promoted and facilitated by the register over the last 40 years.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_11 | Pages 31 - 31
1 Aug 2018
Malchau H Svensson K Mohaddes M Rolfson O Graves S Kärrholm J
Full Access

Deep infection after THA is a devastating complication that implies major suffering for the patients and large costs for society. Reports from multiple national and regional registries show increasing incidence of deep infection. Is this a consequence of improved diagnostics, changed virulence of the causative organism, increased co-morbidity of the patients?

An open database will be setup and hosted by an existing, high quality registry. All possible variables including patient demographic, detailed surgical information, bacteria/fungus characteristics, antibiotic treatment, radiographic findings and follow-up for 3 years will be collected. The incoming data will be displayed on a dashboard with continuous analyses and statistics. Any individual surgeon or hospital can report data.

A board with members from the International Hip Society and the International Society of Arthroplasty Registries will supervise the process and facilitate scientific analyses from collected data.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_1 | Pages 25 - 25
1 Jan 2018
Malchau H Galea V Connelly J Shareghi B Kärrholm J Sköldenberg O Laursen M Bragdon C Muratoglu O
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Osteolysis secondary to ultra-high molecular weight polyethylene (UHMWPE) wear is a leading cause of late-term implant failure via aseptic loosening in patients treated with total hip arthroplasty (THA). Radiation crosslinking of UHMWPE has been shown to decrease wear. However, the resulting polymer (crosslinked-PE) has a high free radical content. Two different methods that have been used to reduce the remaining free radicals are mechanical annealing and chemical stabilization using Vitamin E, a free radical scavenger.

The primary purpose of the current study was to evaluate and compare the wear properties of vitamin E-doped crosslinked-PE (VEPE) and one formulation of mechanically annealed crosslinked-PE using radiostereometric analysis (RSA) in patients five years after primary THA. We also sought to understand the association between polyethylene wear and patient-reported outcome measures (PROMs).

Three-hundred and five patients from six international centers were enrolled. Seventy-six percent were treated with highly-crosslinked (95 kGy) VEPE liners, and the rest received moderately-crosslinked (50 kGy) (ModXL), mechanically annealed liners. Data was collected prospectively at one-, two-, and five-year intervals.

At the 5-year follow-up, proximal femoral head penetration into the VEPE liners (median = 0.05mm (range, −0.03–1.20)) was significantly lower than the penetration into the ModXL liners (median = 0.15mm (range, −0.22–1.04)) (p<0.001). In the VEPE cohort the median proximal penetration did not increase from one- to five-year follow-up (p=0.209). In contrast, there was a significant increase in femoral head penetration for the ModXL group (p<0.001) during that same time. Multivariable regression showed that the only variable predictive of increased wear was ModXL liner type (B=0.12, p<0.001). There were no differences in PROMs between the liner groups, and there was no correlation between polyethylene wear and PROMs for the cohort as a whole.

The current study is the largest analysis of polyethylene wear at five-year follow-up using the RSA technique. We observed similar bedding in through the two-year interval between the two liner types, however, there was significantly more wear in the ModXL cohort at five-years. Currently, the wear rates for both liner groups are below the osteolysis threshold and have not led to any implant failures via aseptic loosening. Continued follow-up will provide a better understanding of the association between wear rate and clinical outcomes.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_1 | Pages 66 - 66
1 Jan 2018
Muratoglu O Suhardi V Bichara D Freiberg A Rubash H Malchau H Oral E
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The gold standard for PJI treatment comprises the use of antibiotic-loaded bone cement spacers, which are limited in their load bearing capacity[1]. Thus, developing an antibiotic-eluting UHMWPE bearing surface can improve the mechanical properties of spacers and improve the quality of life of PJI patients. In this study, we incorporated vancomycin into UHMWPE to investigate its elution characteristics, mechanical properties and its efficacy against an acute PJI in an animal model.

Vancomycin hydrochloride was incorporated into UHMWPE (2 to 14%) by blending and consolidation. We studied drug elution with blocks in PBS and UV-Vis spectroscopy at 280 nm. We determined the tensile mechanical properties and impact strength [3]. We implanted osteochondral plugs in rabbits using either control UHMWPE, bone cement (40g) containing vancomycin (1g) and tobramycin (3.6g) or vancomycin-eluting UHMWPE (n=5) plugs in the patellofemoral groove of rabbits. All rabbits received a beaded titanium rod in the tibial canal. All groups received two doses of 5×107 cfu of bioluminescent S. aureus in the distal tibial canal prior to insertion of the rod and the articular space after closure of the joint capsule. No intravenous antibiotics were used. Bioluminescence signal was measured when the rabbits expired, or at 21-day post-op. Hardware, polyethylene implants, and joint tissues were sonicated to further quantify live bacteria via plate seeding.

Vancomycin elution increased with increasing drug loading. Vancomycin elution above MIC for 3 weeks and optimized mechanical properties were obtained at 6–7 wt% vancomycin loading in UHMWPE. In our lapine acute infection model using bioluminescent S. aureus, knees treated with UHMWPE without antibiotics and bone cement containing vancomycin and tobramycin had significantly higher bioluminescence compared to those treated with vancomycin-eluting UHMWPE.

These results suggest that an antibiotic-eluting UHMWPE spacer with acceptable properties as a bearing surface could be used to treat periprosthetic joint infection in lieu of bone cement spacers and this could allow safer load bearing and a higher quality of life for the patients during treatment. In addition, this presents a safer alternative in cases where the second stage surgery for the implantation of new components is hindered.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_12 | Pages 48 - 48
1 Jun 2017
Cnudde P Nemes S Bülow E Timperley A Kärrholm J Malchau H Garellick G Rolfson O
Full Access

Prospectively collected data is an important source of information subjected to change over time. What surgeons were doing in 1999 might not be the case anymore in 2016 and this change in time also applies to a number of factors related to the performance and outcome of total hip replacement. We evaluated the evolution of factors related to the patient, the surgical procedure, socio-economy and various outcome parameters after merging the databases of the Swedish Hip Arthroplasty Register, Statistics Sweden and the National Board of Health and Welfare.

Data on 193,253 THRs (164,113 patients) operated between 1999 and 2012 were merged with databases including general information about the Swedish population and about hospital care. We studied the evolution of surgical volume, patient demographics, socio-economic factors, surgical factors, length of stay, mortality rate, adverse events, re-operation and revision rates and PROMs.

Most patients were operated because of primary osteoarthritis and this share increased further during the period at the expense of decreasing number of patients with inflammatory OA and hip fracture. Comorbidity and ASA scores increased for each year. The share of all cemented implants has dropped from 92% to 68% with a corresponding increase of all uncemented from 2% to 16%.

Length of stay decreased with about 50 percent to 4.5 days in 2012. The 30- and 90-day mortality rate dropped to 0.4% and 0.7%. Re-operation and revision rates at 2 years were lower in the more recent years. The postoperative PROMs are improving despite the preoperative pain scores getting worse.

Even in Sweden, always been considered as a very conservative country with regards to hip replacement surgery, the demographics of the patients, the comorbidities and the primary diagnosis for surgery are changing. Despite these changes the outcomes like mortality, re-operations, revisions and PROMs are improving.


The Bone & Joint Journal
Vol. 99-B, Issue 5 | Pages 577 - 584
1 May 2017
Nebergall AK Greene ME Laursen MB Nielsen PT Malchau H Troelsen A

Aims

The objective of this five-year prospective, blinded, randomised controlled trial (RCT) was to compare femoral head penetration into a vitamin E diffused highly cross-linked polyethylene (HXLPE) liner with penetration into a medium cross-linked polyethylene control liner using radiostereometric analysis.

Patients and Methods

Patients scheduled for total hip arthroplasty (THA) were randomised to receive either the study E1 (32 patients) or the control ArComXL polyethylene (35 patients). The median age (range) of the overall cohort was 66 years (40 to 76).


The Bone & Joint Journal
Vol. 99-B, Issue 4_Supple_B | Pages 33 - 40
1 Apr 2017
Galea VP Laaksonen I Matuszak SJ Connelly JW Muratoglu O Malchau H

Aims

Our first aim was to determine whether there are significant changes in the level of metal ions in the blood at mid-term follow-up, in patients with an Articular Surface Replacement (ASR) arthroplasty. Secondly, we sought to identify risk factors for any increases.

Patients and Methods

The study involved 435 patients who underwent unilateral, metal-on-metal (MoM) hip resurfacing (HRA) or total hip arthroplasty (THA). These patients all had one measurement of the level of metal ions in the blood before seven years had passed post-operatively (early evaluation) and one after seven years had passed post-operatively (mid-term evaluation). Changes in ion levels were tested using a Wilcoxon signed-rank test. We identified subgroups at the highest risk of increase using a multivariable linear logistic regression model.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_6 | Pages 126 - 126
1 Mar 2017
Zumbrunn T Duffy M Rubash H Malchau H Muratoglu O Varadarajan KM
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One of the key factors responsible for altered kinematics and joint stability following contemporary total knee arthroplasty (TKA) is resection of the anterior cruciate ligament (ACL). Therefore, retaining the ACL is often considered to be the “holy grail” of TKA. However, ACL retention can present several technical challenges, and in some cases may not be viable due to an absent or non-functional ACL. Therefore, the goal of this research was to investigate whether substitution of ACL function through an anterior post mechanism could improve kinematic deficits of contemporary posterior cruciate ligament (PCL) retaining (CR) implants. This was done using KneeSIM, a previously established dynamic simulation tool based on an Oxford-rig setup. Deep knee bend, chair-sit, stair-ascent and walking were simulated for a contemporary ACL sacrificing (CR) implant, two ACL retaining implants, and an ACL substituting and PCL retaining implant. The motion of the femoral condyles relative to the tibia was recorded for kinematic comparisons.

Our results revealed that, like ACL retaining implants, the ACL substituting implant could also provide kinematic improvements over contemporary ACL sacrificing implants by reducing early posterior femoral shift and preventing paradoxical anterior sliding. Such ACL substituting implants may be a valuable addition to the armament of joint surgeons, allowing them to provide improved knee function even when ACL retention is not feasible. Further research is required to investigate this mechanism in vitro and in vivo to verify the results of the simulations, and to determine whether kinematic improvements translate into improved clinical outcomes.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_5 | Pages 69 - 69
1 Mar 2017
Muratoglu O Oral E Suhardi V Bichara D Rubash H Freiberg A Malchau H
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Introduction

Radiation cross-linking of ultrahigh molecular weight polyethylene (UHMWPE) has reduced the in vivo wear and osteolysis associated with bearing surface wear (1), significantly reducing revisions associated with this complication (2). Currently, one of the major and most morbid complications of joint arthroplasty is peri-prosthetic infection (3). In this presentation, we will present the guiding principles in using the UHMWPE bearing surface as a delivery device for therapeutic agents and specifically antibiotics. We will also demonstrate efficacy in a clinically relevant intra-articular model.

Materials and Methods

Medical grade UHMWPE was molded together with vancomycin at 2, 4, 6, 8, 10 and 14 wt%. Tensile mechanical testing and impact testing were performed to determine the effect of drug content on mechanical properties. Elution of the drug was performed in phosphate buffered saline (PBS) for up to 8 weeks and the detection of the drug in PBS was done by UV-Vis spectroscopy. A combination of vancomycin and rifampin in UHMWPE was developed to address chronic infection and layered construct containing 1 mm-thick drug-containing UHMWPE in the non-load bearing regions was developed for delivery. In a lapine (rabbit) intra-articular model (n=6 each), two plug of the layered UHMWPE construct were placed in the trochlear grove of the rabbit femoral surface and a porous titanium rod with a pre-grown biofilm of bioluminescent S. Aureus was implanted in the tibia. Bioluminescent imaging was employed to visualize and quantify the presence of the bacteria up to 3 weeks.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_4 | Pages 135 - 135
1 Feb 2017
Varadarajan KM Patel R Zumbrunn T Rubash H Malchau H Freiberg A Muratoglu O
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Introduction

Dual-mobility (DM) liners provide increased range of motion and stability. However, large head diameters have been associated with anterior hip pain due to impingement with surrounding soft-tissues, particularly the iliopsoas. Further, during hip extension the liner can get trapped due to anterior soft-tissue impingement that resists rotation being imparted to the liner from posterior stem-liner contact. Over time this can cause liner rim damage, leading to intra-prosthetic dislocation of the small diameter inner head. To address this, an anatomically contoured dual mobility (ACDM) liner was designed to reduce the volume of the liner below the equator that can interact with soft-tissues (Fig. 1). In this study, we utilized finite element analysis to evaluate tendon-liner contact pressure and tendon stresses with ACDM and conventional designs during hip extension, wherein the posterior edge of liner is in contact with the stem while the anterior edge is exposed to the soft-tissue.

Methods

The average uniaxial stiffness (350 N/mm), and average dimensions (width × thickness = 14mm × 4mm) of 10 cadaver psoas tendon samples were determined in a separate study. The iliopsoas tendon was modelled as a Yeoh hyper-elastic material, and the material constants were tuned to match the experimental uniaxial test data. Cadaver specific FEA models were created for 5 specimens (10 hips) using computed tomography (CT) scans. The implant components were modeled as being rigid relative to the iliopsoas tendon. The iliopsoas tendon was modelled as extending from its insertion point on the lesser trochanter to the psoas notch on the pelvis for hip flexion angles of −15°, 0°, 15° and 30°. Appropriately sized DM components were implanted virtually for each specimen. Once placed in its proper position, the liner was rotated about the flexion axis until it contacted the stem posteriorly to represent its orientation during hip extension (Fig. 2). A 500N tensile load was applied to the iliopsoas tendon and the average/max stresses within the tendon, and average/max contact pressures between the tendon and liner were measured.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 99 - 99
1 Feb 2017
Bragdon C Hussey D Madanat R Donahue G Rolfson O Muratoglu O Malchau H
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Introduction

When following patients with metal-on-metal (MoM) hip replacements, current evidence suggests that orthopaedic surgeons should avoid reliance on any single investigative tool. In 2014, guidelines for stratifying patients with MoM hip replacement into groups of low, medium, and high risk of failure based on multiple criteria were published. However, such risk stratification guidelines can be difficult to interpret due to the numerous risk factors related to MoM hip replacements. This is especially true for patients with various (high and low) risk levels for different criteria within the guidelines.

The first purpose of this study was to assess if a scoring system can be applied to the current MoM guidelines. The second purpose was to test, using this scoring system, how the contemporary guidelines would classify a cohort of patients with a recalled MoM hip replacement system.

Methods

The study population consisted of 1301 patients (1434 hips) enrolled from September 2012 to June 2015 in a multicenter follow-up study of a recalled MoM hip replacement system at a mean of 6.2 (range 2.4 – 11.2) years from index surgery. Eleven required scoring criteria were determined based on existing follow-up algorithm recommendations and consisted of patient factors, symptoms, clinical status, implant type, metal ion levels, and radiographic imaging results. Criteria considered ‘low’ risk were given 1 point, 2 points for ‘moderate’ risk, and 3 points for the ‘high’ risk group. Forward stepwise logistic regression was conducted to determine the minimum set of predictive variables for risk of revision and assign variable weights. The MoM risk score for each hip was then created by averaging the weighted values of each predictive variable.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 100 - 100
1 Feb 2017
Bragdon C Donahue G Lindgren V Galea V Madanat R Muratoglu O Malchau H
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Introduction

Complication and revision rates have shown to be high for all metal-on-metal (MoM) bearings, especially for the ASR Hip System (ASR hip resurfacing arthroplasty (HRA) and ASR XL total hip arthroplasty (THA)). This prompted the global recall of the ASR Hip System in 2010. Many studies have previously explored the association between female gender and revision surgery MoM HRA implants; yet less research has been dedicated to exploring this relationship in MoM THA.

The first purpose of this study was to assess the associations between gender and implant survival, as well as adverse local tissue reaction (ALTR), in patients with MoM THA. Secondly, we sought to report the differences between genders in metal ion levels and patient reported outcome measures (PROMs) in patients with MoM THA.

Methods

The study population consisted of 729 ASR XL THA patients (820 hips) enrolled from September 2012 to June 2015 in a multicenter follow-up study at a mean of 6.4 (3–11) years from index surgery. The mean age at the time of index surgery was 60 (22–95) years and 338 were women (46%). All patients enrolled had complete patient and surgical demographic information, blood metal ion levels and PROMs obtained within 6 months, and a valid AP pelvis radiograph dating a maximum of 2 years prior to consent. Blood metal ion levels and PROMs were then obtained annually after enrollment. A sub-set of patients from a single center had annual metal artifact reduction sequence (MARS) MRI performed and were analyzed for the presence of moderate-to-severe ALTR.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 128 - 128
1 Feb 2017
Bragdon C Galea V Donahue G Lindgren V Troelsen A Marega L Muratoglu O Malchau H
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Introduction

Studies of metal-on-metal (MoM) hip resurfacing arthroplasty (HRA) have reported high complication and failure rates due to elevated metal ion levels. These rates were shown to be especially high for the Articular Surface Replacement (ASR) HRA, possibly due to its unique design. Associations between metal ion concentrations and various biological and mechanical factors have been reported. Component positioning as measured by acetabular inclination has been shown to be of especially strong consequence in metal ion production in ASR HRA patients, but few studies have evaluated acetabular anteversion as an independent variable.

The primary objective of this study was to evaluate the associations between component orientation, quantified by acetabular inclination and anteversion, and blood metal ions. Secondly, we sought to report whether conventional safe zones apply to MoM HRA implants or if these implants require their own positioning standards.

Methods

We conducted a multi-center, prospective study of 512 unilateral ASR HRA patients enrolled from September 2012 to June 2015. At time of enrollment our patients were a mean of 7 (3–11.5) years from surgery. The mean age at surgery was 56 years and 24% were female. All subjects had complete demographic and surgical information and blood metal ions. In addition, each patient had valid AP pelvis and shoot-though lateral radiographs read by 5 validated readers measuring acetabular abduction and anteversion, and femoral offset. A multivariate logistic regression was used with high cobalt or chromium (greater than or equal to 7ppb) as the dependent variable. The independent variables were: female gender, UCLA activity score, age at surgery, femoral head size, time from surgery, femoral offset, acetabular abduction, and acetabular anteversion.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 34 - 34
1 Feb 2017
Bragdon C Barr C Nebergall A Rolfson O Troelsen A Rubash H Malchau H Greene M
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Introduction

In vitro studies showed that the anti-oxidative properties of vitamin E stabilize free radicals while retaining the mechanical strength of UHMWPE. The purpose was to evaluate vitamin E diffused polyethylene (VEPE) wear and stability of femoral components using RSA. Patient reported outcome measures (PROMs) were evaluated to determine the clinical outcome at 5 years.

Methods

48 patients (52 hips), with osteoarthritis, participated in a 5 year RSA study. Each patient received a VEPE liner, a porous titanium coated shell, and an uncemented stem with a 32mm head. Tantalum beads were inserted into the VEPE and the femur to measure head wear and stem stability using RSA. RSA and PROM follow-up was obtained postoperatively, 6 months, 1, 2, 3, and 5 years after surgery. The Wilcoxon signed-ranks test determined if changes in penetration or migration were significant (p≤0.05).


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 51 - 51
1 Feb 2017
Bragdon C Barr C Berry D Della Valle C Garvin K Johanson P Clohisy J Malchau H
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Introduction

The first highly crosslinked and melted polyethylene acetabular component for use in total hip arthroplasty was implanted in 1998 and femoral heads larger than 32mm in diameter introduced 2004.

The purpose of this study was to re-assemble a previous multi-center patient cohort in order to evaluate the radiographic and wear analysis of patients receiving this form of highly crosslinked polyethylene articulating against large diameter femoral heads at a minimum of 10 years follow-up.

Methods

Two centers contributed patients to this ongoing clinical study. Inclusion criteria for patients was: primary THR; femoral heads greater than 32mm; minimum 10 year follow-up. 69 hips have been enrolled with an average follow-up of 11.2 years (10–15), 32 females (50%). Wear analysis was performed using the Martell Hip Analysis software. Radiographic grading was performed on the longest follow-up AP hip films. The extent of radiolucency in each zone greater than 0.5mm in thickness was recorded along with the presence of sclerotic lines and osteolysis.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 52 - 52
1 Feb 2017
Bragdon C Barr C Berry D Della Valle C Garvin K Johanson P Clohisy J Malchau H
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Introduction

The first highly crosslinked and melted polyethylene acetabular component for use in total hip arthroplasty was implanted in 1998. Numerous publications have reported reduced wear rates and a reduction in particle induced peri-prosthetic osteolysis at short to mid-term follow-up.

The purpose of this study was to re-assemble a previous multi-center patient cohort in order to evaluate the radiographic and wear analysis of patients receiving this form of highly crosslinked polyethylene articulating against 32mm femoral heads or less at a minimum of 13 years follow-up.

Methods

Inclusion criteria for patients was a primary THR with femoral heads 32mm or less and a minimum 13 year follow-up. 139 hips have been enrolled with an average follow-up of 13.7 years (13–16), 80 females (57%). Wear analysis was performed using the Martell Hip Analysis software. Radiographic grading was performed on the longest follow-up AP hip films. The extent of radiolucency in each zone greater than 0.5mm in thickness was recorded along with the presence of sclerotic lines and osteolysis.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_11 | Pages 38 - 38
1 Jun 2016
Mohaddes M Cnudde P Malchau H Kärrholm J
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Introduction

Stem revision with retention of the old cement mantle (cement-in-cement revision) in cases with an intact cement/bone interface is an appealing option. There has been an increasing use of this technique. In 2014 this cement-in- cement technique was used in 10% of all stem revisions reported to the Swedish Hip Arthroplasty Register (SHAR). We analysed the outcome of cement-in-cement stem revisions reported to the SHAR during years 2001–2014

Patients/Materials & Methods

Since 2001 1292 cement-in-cement revisions (study group), performed with a short (≤150 mm) Exeter stem (n=973) or a Lubinus stem (n=319) were reported to the SHAR. Stem revisions, using short Exeter and Lubinus stems without the use of the cement-in-cement technique (n=2893) acted as the control group in this analysis. Both groups were comparable regarding primary diagnosis. In the study group there were more females and the mean age (73 years) was 2 year older (p<0.001). The primary outcome was re-revision due to all causes (n=413). Re-revision of the stem due to all causes, infections excluded (n=212) was used as secondary outcome. Survival analysis using Kaplan-Meier was performed.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_11 | Pages 41 - 41
1 Jun 2016
Mohaddes M Cnudde P Rolfson O Malchau H Kärrholm J
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Introduction

Dislocation as a primary cause of revision has been on the increase in Sweden (14% in 2014). The increasing use of Dual Mobility cups (DMC) could well be explained by the increased revision burden due to dislocation, patients undergoing revision having increased comorbidities and reports that dual articular cup designs reduce the risk of dislocation. The aim of this study was to analyze the change in utilization pattern of the dual articular designs used in acetabular revision surgery in Sweden. The short-term survival of DMC was compared to traditional designs.

Patients/Materials & Methods

During years 2004–2014, 1111 (925 cemented) revisions performed with a DMC design were reported to SHAR. About half (n=426) of these cases were first time revisions performed due to dislocation. During the same time period 520 dislocations were revised for dislocation using a standard cemented cup. There was no differences regarding the age, gender and primary diagnosis (p≥0.12) between the two groups. A second cup revision for all reasons and specifically for dislocation was used as end-point. Kaplan-Meier analysis was performed.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_10 | Pages 154 - 154
1 May 2016
Zumbrunn T Varadarajan K Rubash H Malchau H Li G Muratoglu O
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INTRODUCTION

In native knees anterior cruciate ligament (ACL) and asymmetric shape of the tibial articular surface with a convex lateral plateau are responsible for differential medial and lateral femoral rollback. Contemporary ACL retaining total knee arthroplasty (TKA) improves knee function over ACL sacrificing (CR) TKA; however, these implants do not restore the asymmetric tibial articular geometry. This may explain why ACL retention addresses paradoxical anterior sliding seen in CR TKA, but does not fully restore medial pivot motion. To address this, an ACL retaining biomimetic implant, was designed by moving the femoral component through healthy in vivo kinematics obtained from bi-planar fluoroscopy and sequentially removing material from a tibial template. We hypothesized that the biomimetic articular surface together with ACL preservation would better restore activity dependent kinematics of normal knees, than ACL retention alone.

METHODS

Kinematic performance of the biomimetic BCR design (asymmetric tibia with convex lateral surface), a contemporary BCR implant (symmetric shallow dished tibia) and a contemporary CR implant (symmetric dished tibia) was analyzed using KneeSIM software. Chair-sit, deep knee bend, and walking were analyzed. Components were mounted on an average bone model created from magnetic resonance imaging (MRI) data of 40 normal knees. Soft-tissue insertions were defined on the average knee model based on MRI data, and mechanical properties were obtained from literature. Femoral condyle center motions relative to the tibia were tracked to compare different implant designs.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_10 | Pages 158 - 158
1 May 2016
Graves S Lorimer M Bragdon C Muratoglu O Malchau H
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Introduction

Infection remains a serious complication following primary total hip arthroplasty (THA). Many factors including primary diagnosis, comorbidities and duration of procedure are known to influence the rate of infection. Although the association between patient and surgical factors is increasingly well understood, little is known about the role of the prosthesis. This analysis from the Australian Registry (AOANJRR) was undertaken to determine if revision for infection varied depending on the type of bearing surface used.

Methods

Three different bearing surfaces, ceramic on ceramic (CoC), ceramic on cross-linked polyethylene (CoXP) and metal on cross-linked polyethylene (MoXP) were compared. The study population included all primary THA undertaken for OA using these bearing surfaces and reported to the AOANJRR between 1999 and 2013. Kaplan-Meier survivorship curves were compiled with revision for infection as the end point. Hazard Ratios (HR) from Cox proportional hazards models were used to compare revision rates. Sub analysis examining the effect of age, gender, fixation of the femoral stem and femoral head size. To ensure there was no confounding due to differences in femoral and acetabular component selection a further analysis was undertaken which compared the three different bearings with the same stem and acetabular component combinations.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_9 | Pages 15 - 15
1 May 2016
Varadarajan K Zumbrunn T Duffy M Patel R Freiberg A Malchau H Rubash H Muratoglu O
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Introduction

Dual Mobility (DM) implants have gained popularity for the treatment and prevention of hip dislocation, with increased stability provided by a large diameter mobile liner. However, distal regions of the liner can impinge on soft-tissues like hip capsule and iliopsoas, leading to anterior hip pain. Additionally, soft-tissue impingement may trap the mobile liner, leading to excessive loading of the liner rim, from engagement with the femoral stem, and subsequent intra-prosthetic dislocation. The hypothesis of this study was that reducing the liner profile below the equator (contoured design) can mitigate soft-tissue impingement without compromising inner-head pull-out resistance and overall hip joint stability (Fig. 1).

Methods

The interaction of conventional and contoured liners with anterior soft-tissues was evaluated in 10 cadaveric hips (5 specimens; 2 male, 3 female; age 65 ± 10 yrs; liner diameter 42–48mm) via visual observation and fluoroscopic imaging. A metal wire was sutured to the deep fibers of the iliopsoas tendon/muscle, and metal wires were embedded in the mobile liners for fluoroscopic visualization (Fig. 2). All soft-tissue except the anterior hip capsule and iliopsoas was removed, and a rope was attached to the iliopsoas to apply tension along its natural orientation.

Resistance to inner-head pull-out was evaluated via Finite Element Analysis (FEA) by simulating a full cycle of insertion of the inner head into the mobile liner and subsequent pullout. The femoral head, acetabular shell, and stem were modeled as rigid, while the mobile liner was modeled as plastically deformable. Hip joint stability was evaluated by dynamic simulations in for two dislocation modes: (A) Posterior dislocation (at 90° hip flexion) with internal hip rotation; (B) Posterior dislocation (starting at 90° flexion) with combined hip flexion and adduction. A 44 mm diameter conventional and a 44 mm contoured liner were evaluated during these tests.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_9 | Pages 122 - 122
1 May 2016
Patel R Zumbrunn T Varadarajan K Freiberg A Rubash H Muratoglu O Malchau H
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Introduction

Dual-mobility (DM) liners have increased popularity due to the range of motion and stability provided by these implants. However, larger head diameters have been associated with anterior hip pain, due to surrounding soft-tissue impingement, particularly the iliopsoas. To address this, an anatomically contoured dual mobility (ACDM) liner was designed by reducing the volume of the liner below the equator (Fig1). Previous cadaver studies have shown that the ACDM significantly reduces iliopsoas tenting and trapping of the liner compared to conventional designs. We created a finite element study based on previous cadaver testing to further analyze the effectiveness of the ACDM design in reducing soft-tissue impingement, specifically the tendon-liner contact pressure and the tendon stress.

Methods

The finite element model was developed within COMSOL 4.3b. The psoas tendon was modelled as a Yeoh hyper-elastic Material, which uses 3 constants (c1-c3), density (1.73g/cm3) and a bulk modulus (26GPa)[Hirokawa,2000]. In a previous, separate study, the average stiffness of 10 psoas tendon samples (5 cadavers), were measured to be 339[N/mm] in the linear region with average width and thickness of 14mmX4mm. The 3 constants were tuned to match experimental uniaxial test data, and were 5[GPa], 0[Gpa], and 46[GPa] for c1, c2, and c3 respectively.

The implant components were rigidly modeled relative to the psoas. Cadaver specific CT models were used to create the FEA geometry. The insertion points for the Psoas were digitally determined on the proximal end of the lesser trochanter, and the psoas notch on the pelvis for hip flexion angles of −15°, 0°, 15° and 30°. These insertion points determined the length of the psoas and its relative position to the femoral head in 3D. The specific liner size and position for each cadaver was determined by implant planning with the CT models. In this abstract, we only present data for 2 specimens (left/right hips) with 44mm conventional DM, and 44mm ACDM, matching specimen anatomy. A 500N tensile load was applied to the psoas tendon proximally to simulate moderate physiological loading, the average/max stresses and contact pressures between the psoas and the two liner designs were determined.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_9 | Pages 80 - 80
1 May 2016
Nebergall A Freiberg A Greene M Malchau H Muratoglu O Rowell S Zumbrunn T Varadarajan K
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Introduction

The large diameter mobile polyethylene liner of the dual mobility implant provides increased resistance to hip dislocation. However, a problem specific to the dual mobility system is intra-prosthetic dislocation (IPD), secondary to loss of the retentive rim, causing the inner head to dissociate from the polyethylene liner. We hypothesized that impingement of the polyethylene liner with the surrounding soft-tissue inhibits liner motion, thereby facilitating load transfer from the femoral neck to the liner and leading to loss of retentive rim over time. This mechanism of soft-tissue impingement with the liner was evaluated via cadaver experiments, and retrievals were used to assess polyethylene rim damage.

Methods

Total hip arthroplasty was performed on 10 cadaver hips using 3D printed dual mobility components. A metal wire was sutured to the posterior surface (underside) of the iliopsoas, and metal wires were embedded into grooves on the outer surface of the liner and inner head to identify these structures under fluoroscopy. Tension was applied to the iliopsoas to move the femur from maximum hyperextension to 90° of flexion for the purpose of visualizing the iliopsoas and capsule interaction with the mobile liner. The interaction of the mobile liner with the iliopsoas was studied using fluoroscopy and direct visual observation. Fifteen retrieved dual mobility liners were assessed for rim edge and rim chamfer damage. Rim edge damage was defined as any evidence of contact, and rim chamfer damage was classified into six categories: impact ribs on the chamfer surface, loss of machining marks, scratching or pitting, rim deformation causing a raised lip, a rounded rim edge, or embedded metal debris.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_10 | Pages 155 - 155
1 May 2016
Zumbrunn T Malchau H Rubash H Muratoglu O Varadarajan K
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INTRODUCTION

In native knees the anterior cruciate ligament (ACL) plays a major role in joint stability and kinematics. Sacrificing the ACL in contemporary total knee arthroplasty (TKA) is known to cause abnormal knee motion, and reduced function. Hence, there is growing interest in the development of ACL retaining TKA implants. Accommodation of ACL insertion around the tibial eminence is a challenge with these designs. Therefore, a reproducible and practical test setup is necessary to characterize the strength of the ACL/bone construct in ACL retaining implants. Seminal work showed importance of loading the ACL along its anatomical orientation. However, prior setups designed for this purpose are complex and difficult to incorporate into a standardized test for wide adoption. The goal of this study was to develop a standardized and anatomically relevant test setup for repeatable strength assessment of ACL construct using basic force-displacement testing equipment.

METHODS

Cadaver knees were positioned with the ACL oriented along the loading axis and being the only connection between femur and tibia. 15° knee flexion was selected based on highest ACL tensions reported in literature. Therefore, the fixtures were adjusted accordingly to retain 15° knee flexion when the ACL was tensioned. The test protocol included 10 cycles of preconditioning between 6N and 60N at 1mm/s, followed by continuous distraction at 1mm/s until failure (Fig. 1). Eleven cadaveric knees (4 male, 7 female; 70.9 yrs +/−13.9 yrs) were tested using this setup to characterize a baseline ACL pullout strength (peak load to failure) in native knees.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_3 | Pages 63 - 63
1 Jan 2016
Varadarajan KM Zumbrunn T Duffy M Rubash HE Malchau H Freiberg A Muratoglu O
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Introduction

Dual Mobility (DM) implants have gained popularity for the treatment and prevention of hip dislocation, with increased stability provided by a large diameter mobile insert. However, distal regions of the insert may impinge on soft tissues like the iliopsoas, leading to groin pain. Additionally, soft-tissue impingement may trap the mobile insert, leading to excessive loading of the insert rim from engagement with the femoral neck and subsequent intra-prosthetic dislocation. To address this, an Anatomically Contoured Dual Mobility (ACDM) insert with a soft-tissue friendly distal geometry was developed (Fig.1). Previously, the ACDM insert was shown to maintain the femoroacetabular contact area and joint stability of a conventional DM insert [Duffy et al. BJJ 2013, 95-B:34, p298; Zumbrunn et al. BJJ 2013, 95-B:34, p605]. The goal of this study was to utilize cadaver specimens to verify whether the ACDM insert could reduce soft-tissue impingement relative to a conventional DM insert.

Methods

Fluoroscopic imaging was used to evaluate soft-tissue interaction with ACDM and conventional DM inserts in four cadaver hips (Fig. 2). A metal wire was sutured to the deep fibers of the iliopsoas muscle/tendon, and metal wires were embedded in the inner head and the mobile insert for fluoroscopic visualization. All soft tissue except the anterior hip capsule and iliopsoas were removed, and a rope was attached to the iliopsoas to apply tension along its native orientation. A femoral stem and a DM acetabular shell were implanted sothe ACDM or conventional DM inserts, together with the inner heads, could be inserted. Fluoroscopic images of the hip joint were taken at maximum hyperextension, 0°, 15° and 30° hip flexion with the insert positioned in neutral and anteverted orientations (Fig. 2). Neutral orientation corresponded to the insert axis parallel to the femoral neck, while anteverted orientation corresponded to a flexed insert that contacted the femoral neck posteriorly.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_3 | Pages 82 - 82
1 Jan 2016
Nebergall A Greene M Sillesen N Rubash HE Kwon Y Malchau H
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Introduction

Osteolysis caused by wear of the ultrahigh molecular weight polyethylene (UHMWPE) often leads to failure. Cross-linking improves wear, but also produces residual free radicals that decrease oxidative stability. In vitro studies have shown that the anti-oxidative properties of vitamin E UHMWPE stabilize free radicals while retaining the physical and chemical properties of UHMWPE. The porous surface of the Regenerex™ shell was developed for improved bone in-growth fixation. The increased porosity of the Regenerex™ shell promotes early bony in-growth with the goal of greater long-term stability. The purpose of this study was to evaluate vitamin E infused polyethylene (VEPE) wear and stability of acetabular and femoral components using RSA.

Methods

58 patients (64 observed hips), all with osteoarthritis, gave informed consent to participate in a 5 year RSA study. Each patient received a VEPE liner, a Regenerex™ acetabular shell, and an uncemented stem with either a 32mm or 36 mm cobalt chrome femoral head. Tantalum beads were inserted into the VEPE, the pelvic and the femoral bone to measure head penetration into the polyethylene, and shell and stem stability over time, using RSA. RSA radiographs were scheduled immediately postoperatively (up to 6 weeks) and 6 months, 1, 2, 3, and 5 years after surgery. The Wilcoxon signed-ranks nonparametric test was used to determine if changes in penetration or migration were significant over time at p≤0.05.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_3 | Pages 62 - 62
1 Jan 2016
Varadarajan KM Zumbrunn T Duffy M Rubash HE Malchau H Muratoglu O
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Introduction

In Cruciate Retaining (CR) Total Knee Arthroplasty (TKA), the Posterior Cruciate Ligament (PCL) is preserved but the Anterior Cruciate Ligament (ACL) is sacrificed. In contemporary CR implants, failure to substitute for ACL function causes abnormal knee motion, with the femur being located excessively posterior on the tibia in full extension (Fig. 1), and sliding forward during early flexion. To address this kinematic abnormality, we developed an ACL Substituting Cruciate Retaining (ASCR) TKA implant that substitutes for the absent ACL, while preserving the native PCL. The ASCR tibia includes an ACL substituting post that engages the intercondylar notch of the femoral component in low flexion to act for the missing ACL (Fig. 1). With continued flexion, the post disengages from the femoral component and the native PCL guides further motion of the femur (femoral rollback). Thus the ACL substituting post mimics the native ACL function. The hypothesis of this study was that the ASCR implant can address the abnormal femoral sliding seen in contemporary CR implants.

Methods

The kinematics of an ACL-preserving implant, the ASCR implant, and a contemporary CR implant during deep knee bend was simulated using LifeMOD KneeSIM software (Fig. 2). The PCL was preserved in all implants. Anteroposterior motion of the femoral condyles relative to the tibia was measured. The implants were mounted on an average knee model created from Magnetic Resonance Imaging (MRI) of 40 healthy knees. The medial and lateral collateral ligaments, PCL, ACL (for ACL-preserving implant), quadriceps mechanism, and capsular tension were modeled. The soft-tissue insertions were obtained from the average knee model, and the mechanical properties were obtained from literature.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_3 | Pages 83 - 83
1 Jan 2016
Nebergall A Malchau H Greene M
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Introduction

RSA is widely accepted as a precise method to asses wear and migration early in the postoperative period. In traditional RSA, one segment defines both the acetabular shell and the polyethylene liner. However, inserting beads into the liner permits employment of the shell and liner as two separate segments, thus enabling distinct analysis of the precision of three measurement methods in determining wear and acetabular shell migration. The purpose of this in vivo follow-up study was to determine if assigning the shell and liner as one combined, or two individual segments affected the precision of RSA measurements of wear and shell stability.

Methods

The UmRSA program was used to analyze the double examinations of 51 hips to determine if there was a difference in precision among 3 measurement methods: the shell only, the liner only, and the shell + liner combined segment. Tantalum beads were inserted into the liner and pelvic bone surrounding the shell intraoperatively for the purpose of RSA. Polyethylene wear was measured using point motion of the center of the head with respect to 3 different segments: 1) liner only, 2) the shell only and, 3) shell + liner segment. Cup stability was measured by segment motion comparing the stable pelvic segment to 1) the liner segment, 2) the shell only segment, and 3) the shell + liner segment. The Wilcoxon paired signed-ranks test was used to determine differences in condition number and bead counts among the 3 measurement methods (p ≤0.05).


The Bone & Joint Journal
Vol. 97-B, Issue 5 | Pages 578 - 581
1 May 2015
Rolfson O Malchau H

The limitations and benefits of patient-reported outcome measures, in defining the merits of arthroplasty surgery, are discussed.

Cite this article: Bone Joint J 2015;97-B:578–81.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_19 | Pages 30 - 30
1 Dec 2014
Nortje M Hussey D McLennan-Smith R Dymond I Grobler G Dower B Bragdon C Muratoglu O Malchau H
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Introduction:

The ASR™ Articular Surface Replacement and ASR™ XL Metal-on-Metal systems were recalled due to high revision rates at five years. A worldwide clinical follow-up of patients was initiated. This paper summarizes current findings in South Africa (SA) in comparison with those outside SA (OSA).

Methods:

Patients were followed annually, or until revision, from 10 clinical centers worldwide. Data collected includes demographic, surgical, radiographic, blood metal ion levels, and patient reported outcome measures (PROM).


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 201 - 201
1 Jul 2014
Rowell S Reyes C Malchau H Muratoglu O
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Summary

Four highly cross-linked UHWMPEs except vitamin E-stabilised explants

Introduction

The development of both first and second generation highly cross-linked material focused on stabilizing radiation-induced free radicals as the sole precursor to oxidative degradation; however, secondary in vivo oxidation mechanisms have been identified in both conventional and highly cross-linked UHMWPE, induced by absorbed lipids and cyclic mechanical load. Retrieval studies are reporting in vivo oxidation highly cross-linked retrievals with up to ten year in vivo durations. Preclinical aging tests did not predict these in vivo material changes. With only a decade of these materials in clinical use, retrieval studies are limited to mid-term follow-up. In vitro studies face a challenge in effectively replicating the precise in vivo conditions that lead to this loss of oxidation resistance. In this study, we bypass replicating these in vivo variables by examining surgically-retrieved components, thereby testing material that has been affectively “pre-conditioned” by their in vivo service. After a preliminary post-operative analysis, we subjected retrievals to accelerated aging tests in order to predict the extent to which their oxidative stability had been uniquely compromised in vivo.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 142 - 142
1 Jul 2014
Mohaddes M Malchau H Herberts P Johansson P Kärrholm J
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Summary Statement

We analysed impaction bone grafting used together with cemented or uncemented fixation in acetabular revision surgery. The overall risk for re-revision did not differ between the cemented and uncemented group. However, aseptic loosening was more common in the cemented group.

Background

Several surgical techniques address bone defects in cup revision surgery. Bone impaction grafting, introduced more than thirty years ago, is a biologically and mechanically appealing method. The primary aim of this study was to evaluate the effect of bone impaction grafting when used with uncemented and cemented fixation in cup revision surgery. Uncemented cups resting on more than 50% host bone were used as controls.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 202 - 202
1 Jul 2014
Rowell S Estok D Kreuzer S Malchau H Muratoglu O
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Summary

Sequentially irradiated and annealed UHMWPE hip and knee retrievals showed subsurface in vivo oxidation in both the articular surface and unloaded surfaces, while three of four never-implanted shelf stored liners had oxidation in the bulk.

Introduction

Highly cross-linked polyethylene was developed to improve the wear resistance of UHMWPE bearing surfaces in total hip arthroplasty. First generation irradiated and annealed polyethylene showed high oxidation in vivo, largely attributed to only the partial-quenching of free radicals, along with additional radicals generated during terminal gamma sterilization. A second generation, three-step sequential irradiation and annealing method was advanced with the promise of better oxidative stability and improved mechanical properties. We hypothesised that without the complete elimination of free radicals combined with gas plasma sterilization requiring oxygen-permeable packaging, that this second generation material would be prone to shelf-oxidation in addition to in vivo oxidation.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 605 - 605
1 Dec 2013
Zumbrunn T Varadarajan KM Duffy M Rubash HE Malchau H Freiberg A Muratoglu O
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INTRODUCTION

Femoral head diameter has a major influence on stability and dislocation resistance of the hip joint after Total Hip Arthroplasty (THA). Dual Mobility (DM) implants can also reduce the risk of dislocation due the large diameter mobile liner which forms the femoroacetbular articulation. However, recent studies have shown that large head prostheses can directly impinge against native soft tissues, particularly the iliopsoas, leading to anterior hip pain. Dual mobility systems have emerged as a revision option in the treatment of failed metal on metal devices because of the high incidence of post revision instability secondary to abductor loss and need for capsulectomy. We hypothesized that an Anatomically Contoured Dual Mobility (ACDM) liner could provide joint stability while better accommodating the soft tissues surrounding the hip joint.

METHODS

The dislocation resistance of a 44 mm ACDM implant was compared to that of a 44 mm conventional DM liner. Both implants consisted of a 28 mm inner small diameter head and the liner was abducted to be in the worst case position for dislocation (Fig. 1). The ACDM liner was based on a 44 mm sphere with smaller radii used to contour the peripheral region below the equator of the liner. MSC Adams was used for dynamic simulations based on two previously described dislocation modes: (A) Posterior dislocation (at 90° hip flexion) with internal rotation of the hip and a posterosuperior directed joint force; (B) Posterior dislocation (starting at 90° flexion) with combined hip flexion and adduction and a posteromedial force direction (Fig. 2). Impingement-free motion (motion without neck impingement against the acetabular cup) and jump distance (head separation from acetabulum at dislocation) were measured for each implant. The acetabular cup was placed at 42.5° abduction and 19.7° anteversion, while the femoral component was anteverted by 9.75° based on published data.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 406 - 406
1 Dec 2013
Varadarajan KM Zumbrunn T Rubash HE Malchau H Muratoglu O Li G
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Introduction:

While kinematic abnormalities of contemporary TKA implants have been well established, a solution has not yet been achieved. We hypothesized that contemporary TKA implants are not compatible with normal soft-tissue function and normal knee motion. We propose a novel technique for reverse engineering advanced implant articular surfaces (biomimetic surface), by using accurate 3D kinematics of normal knees. This technique accounts for surgical placement of the implants, and allows design of tibial and femoral articular surfaces in conjunction.

Methods:

Magnetic resonance imaging was used to create 3D knee models of 40 normal subjects (24 male, 16 female, age 29.9 ± 9.7 years), and bi-planar fluoroscopy was used to capture 3D knee motion during a deep knee bend. These data were combined to create a 3D virtual representation of an average normal knee and its motion pathway. A TKA femoral component was mounted on the average knee, and moved through its normal kinematic pathway to carve out an articular surface from a tibial template (Fig. 1 and 2). The geometry of the resulting biomimetic tibia was compared to that of the native tibia, and a contemporary TKA tibial insert that uses the same femoral component.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 408 - 408
1 Dec 2013
Varadarajan KM Duffy M Zumbrunn T Rubash HE Malchau H Freiberg A Muratoglu O
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Introduction:

Large diameter femoral heads have been used successfully to prevent dislocation after Total Hip Arthroplasty (THA). However, recent studies show that the peripheral region of contemporary femoral heads can directly impinge against the native soft-tissues, particularly the iliopsoas, leading to activity limiting anterior hip pain. This is because the spherical articular surface of contemporary prosthesis overhangs beyond that of the native anatomy (Fig. 1). The goal of this research was to develop an anatomically shaped, soft-tissue friendly large diameter femoral head that retains the benefits of contemporary implants.

Methods:

Various Anatomically Contoured femoral Head (ACH) designs were constructed, wherein the articular surface extending from the pole to a theta (θ) angle, matched that of contemporary implants (Fig. 2). However, the articular surface in the peripheral region was moved inward towards the femoral head center, thereby reducing material that could impinge on the soft-tissues (Fig. 1 and Fig. 2). Finite element analysis was used to determine the femoroacetabular contact area under peak in vivo loads during different activities. Dynamic simulations were used to determine jump distance prior to posterior dislocation under different dislocation modes. Published data was used to compare the implant articular geometry to native anatomy (Fig. 3). These analyses were used to optimize the soft-tissue relief, while retaining the load bearing contact area, and the dislocation resistance of conventional implants.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 407 - 407
1 Dec 2013
Varadarajan KM Zumbrunn T Duffy M Rubash HE Malchau H Freiberg A Muratoglu O
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Introduction:

Dual Mobility (DM) hip implants have gained popularity for the treatment and preventions of instability. In DM implants a large diameter mobile insert matches the native femoral head size. However, studies have shown that the peripheral regions of such large diameter implants overhang beyond the native anatomy and can directly impinge against nearby soft tissues, especially the iliopsoas, leading to groin pain (Fig. 1). Soft-tissue impingement can also trap the mobile DM insert, leading to damage of its peripheral rim, which secures the small diameter inner head (Fig. 2). The goal of this research was to develop an anatomically contoured soft-tissue friendly DM insert.

Methods:

Various Anatomically Contoured Dual Mobility (ACDM) insert designs were constructed, wherein the outer articular surface extending from the pole to a theta (θ) angle, matched that of contemporary implants (Fig. 3). However, the articular surface in the peripheral region was moved inward towards the center, thereby reducing implant volume that could impinge on the soft tissue (Fig. 1 and Fig. 3). Finite element analyses were used to determine the insert-acetabular contact area under peak in vivo loads during different activities. Finite element analysis was also used to determine resistance to extraction of the inner head. Published data was used to compare the implant articular geometry to native anatomy. These analyses were used optimize the soft-tissue relief, while matching the load bearing contact area and the resistance to extraction of the inner head in contemporary implants.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 297 - 297
1 Dec 2013
Duffy M Varadarajan KM Zumbrunn T Rubash HE Malchau H Freiberg A Muratoglu O
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Introduction

Large diameter femoral heads provide increased range-of-motion and reduced dislocation rates compared to smaller diameter femoral heads. However, several recent studies have reported that contemporary large head prostheses can directly impinge against the local soft tissues leading to anterior hip pain. To address this we developed a novel Anatomically Contoured large diameter femoral Head (ACH) that maintains the profile of a large diameter femoral head over a hemispherical portion and then contours inward the distal profile of the head for soft-tissue relief. We hypothesized that the distal contouring of the ACH articular surface would not affect contact area. The impact of component placement, femoral head to acetabular liner radial clearance, and joint loading during different activities was investigated.

Methods

A finite element model was used to assess the femoroacetabular contact area of a 36 mm diameter conventional head and a 36 mm ACH (Fig. 1). It included a rigid acetabular shell, plastically deformable UHMWPE acetabular liner, rigid femoral head and rigid femoral stem. The femoral stem was placed at 0°, 10° and 20° of anteversion. The acetabular shell and liner were placed in 20°, 40° and 60° of abduction and 0°, 20° and 40° of anteversion. The femoral head to acetabular liner radial clearances modeled were 0.06 mm, 0.13 mm and 0.5 mm. Three loading cases corresponding to peak in vivo loads during walking, chair sit and deep-knee bend were analyzed (Fig. 2). This allowed a range of component positions and maximum joint loads to be studied.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 298 - 298
1 Dec 2013
Duffy M Varadarajan KM Zumbrunn T Rubash HE Malchau H Freiberg A Muratoglu O
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Introduction

Dual mobility (DM) implants provide increased stability and range-of-motion through the use of a large diameter mobile liner articulating against an acetabular shell. However, recent studies have reported that such contemporary large head prostheses can directly impinge against the local soft tissues leading to anterior hip pain. To address this drawback, a novel Anatomically Contoured Dual Mobility (ACDM) liner was developed that maintains the outer spherical geometry over an approximately hemispherical portion and then contours inward the distal profile of the DM liner for soft-tissue relief. The extent of the inner profile encapsulating the small diameter head is increased to provide more coverage of the head and maintain the inner head pullout force. We hypothesized that the ACDM liner for soft-tissue relief would not affect retention of the small diameter inner head or liner-acetabular load-bearing contact area.

Methods

A finite element model to evaluate head retention and contact mechanics was created with a rigid acetabular shell, a plastically deformable UHMWPE DM liner, a rigid femoral head and a rigid femoral stem. For the head retention analysis, the extent of head coverage (Fig. 1) was optimized to match the inner head pullout force of a conventional DM liner. Contact mechanics of a conventional DM and ACDM liner were analyzed at the maximum joint load of three activities: gait, deep-knee bend and chair sit. One set of simulations was completed with the mobile liner and head axes aligned and another with the axes mal-aligned so that the mobile liner rim was adjacent to the femoral stem neck and the potential area of contact was away from the mobile liner apex. This allowed a broader range of potential contact to be assessed including what was determined to be a worst-case alignment.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 405 - 405
1 Dec 2013
Varadarajan KM Zumbrunn T Rubash HE Malchau H Li G Muratoglu O
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Introduction:

Contemporary Posterior Cruciate Ligament (PCL) retaining TKA implants (CR) are associated with well-known kinematic deficits, such as absence of medial pivot motion, paradoxical anterior femoral sliding, and posterior femoral subluxation at full extension. The hypothesis of this study was that a biomimetic implant, reverse engineered by using healthy knee kinematics to carve the tibial articular surface, could restore normal kinematic patterns of the knee.

Methods:

Kinematics of the biomimetic CR and two contemporary CR implants (A, B) were evaluated during simulated deep knee bend and chair-sit in LifeModeler KneeSIM™ software. Anteroposterior motion of the medial and lateral femoral condyle centers was measured relative to a tibial origin. The implants were mounted on an average knee model created from magnetic resonance imaging (MRI) of 40 healthy knees. The medial and lateral collateral ligaments, posterior cruciate ligament, quadriceps mechanism, and the overall capsular tension were modeled. The soft-tissue insertions were obtained from the average knee model, and the mechanical properties were obtained from literature. In vivo knee kinematics of healthy subjects from published literature was used for reference.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 146 - 146
1 Dec 2013
Padgett DE Dounchis J Bragdon CR Elson L Malchau H
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Introduction:

Acetabular component orientation has been linked to hip stability as well as bearing mechanics such as wear. Previous studies have demonstrated wide variations of cup placement in hip arthroplasty using conventional implantation techniques which rely upon either anatomic landmarks or the use of commercial positioning guides. Enabling technologies such as navigation have been used to improve precision and accuracy. Newer technologies such as robotic guidance have been postulated to further improve accuracy. The goal of our study was to evaluate the clinical reproducibility of a consecutive series of haptically guided THR.

Methods:

119 patients at 4 centers were enrolled. All patients had preoperative CT scans for the purpose of planning cup placement in lateral opening and version using proprietary software (Mako, Ft. Lauderdale, FL). All procedures were performed using a posterolateral approach. Following bone registration, acetabular preparation and component position is performed using haptic guidance. Final implant postion is ascertained by obtaining 5 points about the rim of the acetabular component and recorded. At 6 weeks, all patients had AP and cross-table lateral radiographs which were then analyzed for cup abduction and anteversion using the Hip Analysis Suite software. The goal was to determine the variability between desired preoperative plan, intraoperative measurement and postoperative results.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 234 - 234
1 Dec 2013
Barr C Nebergall A Scarborough D Braithwaite G Kwon Y Rubash HE Muratoglu O Malchau H
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Introduction:

Acetabular cup position is an important factor in successful total hip arthroplasty (THA). Optimal cup placement requires surgeons to possess an accurate perception of pelvic orientation during cup impaction, however, varying pelvic anatomy and limited visual cues in the surgical field may interfere with this process. The purpose of this study was to evaluate the utility of an inertial measurement unit (IMU) in monitoring pelvic position during THA.

Materials & Methods:

Ten patients scheduled to undergo THA were IRB-approved and consented by four surgeons. A small IMU was placed over the patient's sacrum pre-operatively and zeroed in standing position. Pelvic orientation data was streamed and captured wirelessly throughout the procedure. Surgeons were blinded to all data throughout the study period. Prior to cup impaction, the surgeon indicated his intended cup abduction angle and the degree to which the cup impactor was manipulated to compensate for perceived AP pelvic tilt. The degree of pelvic tilt as determined by the IMU (angle β) was then recorded (Figure 1). AP-pelvis radiographs were measured in Martell Hip Analysis Suite post-operatively to calculate the cup abduction angle, which was then compared to the surgeon's intended abduction angle to determine surgeon accuracy. To predict the final cup abduction angle, the degree of pelvic tilt recorded by the IMU (angle β) was subtracted from the abduction angle of the cup impactor (angle α) that was positioned using the OR table as a reference (Figure 1). This value was then compared to the measured post-operative cup abduction angle in order to assess the accuracy of the IMU in measuring pelvic tilt. Surgeon accuracy and IMU accuracy were compared to determine if the IMU was more or less effective than surgeon perception at determining pelvic tilt.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 606 - 606
1 Dec 2013
Zumbrunn T Varadarajan KM Duffy M Rubash HE Malchau H Freiberg A Muratoglu O
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INTRODUCTION

Femoral head diameter has a major influence on stability and dislocation resistance after Total Hip Arthroplasty (THA). Although routine use of large heads is common, several recent studies have shown that contemporary large head prostheses can directly impinge against native soft tissues, particularly the iliopsoas which wraps around the femoral head, leading to refractory anterior hip pain. To address this, we developed a novel Anatomically Contoured large diameter femoral Head (ACH). We hypothesized that anatomical contouring of the ACH implant for soft tissue relief would not compromise dislocation resistance, and the ACH implant would provide increased stability compared to small heads.

METHODS

In this study the dislocation resistance of a 36 mm ACH was compared to that of 28 mm and 36 mm contemporary heads. The ACH implant was based on a 36 mm sphere with smaller radii used to contour the peripheral region below the equator of the head. MSC Adams was used for dynamic simulations based on two previously described dislocation modes: (A) Posterior dislocation (at 90° hip flexion) with internal rotation of the hip and a posterosuperior directed joint force; (B) posterior dislocation (starting at 90° flexion) with combined hip flexion and adduction and a posteromedial force direction (Fig. 1). Impingement-free motion (motion without neck impingement against the acetabular liner) and jump distance (head separation from acetabulum prior to dislocation) were measured to evaluate the dislocation risk of each implant. The acetabular cup was placed at 42.5° abduction and 19.7° anteversion, while the femoral component was anteverted by 9.75° based on published data.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_28 | Pages 1 - 1
1 Aug 2013
Dounchis J Elson L Bragdon CR Padgett D Illgen M Malchau H
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Introduction

In total hip arthroplasty, the positioning of the acetabular cup, in particular, has been shown to play an important role in the survivorship of the prosthetic joint. The commonly accepted “safe zone” extends from 5–30° of anteversion to 30–50° of inclination. However, several studies have utilized a more restrictive safe zone of 5–25° of anteversion and 30–45° of inclination, a modification of the Lewinnek zone. Many attempts have been made to develop a more reliable method of positioning the acetabular component. Robotic-assisted surgery is one such method. The purpose of this study was to compare the resulting position of the acetabular component after robotic-assisted surgery with the intraoperative robotic data to determine if improved accuracy can be achieved with the robotic-assisted method.

Methods

One hundred and nineteen patients received THA, at four different medical centers in the United States, using a haptic robotic arm. Pre-operative CT scans were obtained for all patients and used during the planning of the procedure, at which point the proposed component size and positioning was determined. Preparation of the acetabular bone bed, as well as impaction of the acetabular component itself, was performed using the robotic device.

Using an AP Pelvis and Cross-Table Lateral radiograph, each patient's resulting acetabular inclination and version was measured using the Hip Analysis Suite software. The component position retrieved from the robot was compared to the measured values from the radiographs. The positioning data was compared to two safe zones described above.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 243 - 243
1 Sep 2012
Bragdon C Malchau H Greene M Doerner M Emerson R Gebuhr P Huddleston J Cimbrelo E
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Introduction

Proper cup positioning is a critical component in the success of total hip arthroplasty surgery. A multicenter study has been initiated to study a new type of highly cross-linked polyethylene. This study provides a unique opportunity to a review the acetabular cup placement of over 500 patients implanted in the past 2 years from 13 medical centers from the U.S., Mexico, and Europe.

Methods

482 patients have received primary total hip arthroplasty using components from a single manufacturer in 5 centers in the US and Mexico and 7 centers in Europe. The acetabular anteversion and inclination were measured in post-operative radiographs. An acceptable window of cup position is defined at 5–25° of anteversion and 30–45° of inclination.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 289 - 289
1 Sep 2012
Bragdon C Martell J Jarrett B Clohisy J White R Goldberg V Della Valle C Berry D Johanson P Harris W Malchau H
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Introduction

Total hip replacements using highly cross-linked polyethylene show excellent clinical outcomes, low wear, and minimal lysis at 5 years follow-up. A recent RSA study reports a significant increase in femoral head penetration between 5 and 7 years. This study is a multi-center radiographic analysis to determine whether the RSA observation is present in a large patient cohort.

Methods

Six centers were enrolled for radiographic analysis of primary total hip arthroplasty for standard head sizes (26mm, 28mm, or 32mm). Radiographic inclusion criteria required a minimum of four films per patient at the following time points: 1 year; 2–4.5 years; 4.5–5.5 years; and 5.5–11 years. The Martell Hip Analysis Suite was used to analyze pelvic radiographs resulting in head penetration values. Wear rates were determined in two ways: the longest follow-up radiograph compared to the 1 year film, and individual linear regressions for the early and late periods. For both methods, average wear rates from the early period (1 to 5.5 years) and late period (>5.5 years) were compared using t-tests.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 539 - 539
1 Sep 2012
Bragdon C Doerner M Callanan M Zurakowski D Kwon Y Rubash H Malchau H
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Introduction

Acetabular cup positioning has been linked to dislocation and increased bearing surface wear. A previous study found correlations between patient and surgical factors and acetabular component position. The purpose of this study was to determine if acetabular cup positioning improves when surgeons receive feedback on their performance.

Methods

Post-op anteroposterior (AP) pelvis and cross-table lateral radiographs were previously obtained for 2061 patients who received a total hip arthroplasty (THA) or hip resurfacing from 2004–2008. The surgeries were performed by 7 surgeons. AP radiographs were measured using Hip Analysis Suite to calculate the cup inclination and version angles. Acceptable ranges were defined for abduction (30–45 °) and version (5–25 °). The same surgeons performed a THA or hip resurfacing on 385 patients from January 2009 through June 2010. Cup inclination and version angles for this set of surgeries were compared to surgeries from 2004–2008 to determine if cup inclination and version angles improved in response to previous acetabular cup positioning studies. Improvement in accuracy was assessed by the chi-square test.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 575 - 575
1 Nov 2011
Marchie A Callanan M Bragdon C Zurakowski D Malchau H
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Purpose: The purpose of this study was to determine if correlation exists between acetabular cup positioning and factors relating to the surgeon and patient.

Method: Data for 2063 patients who underwent primary or revision THA from 2004 – 2008 were compiled. The post-op anteroposterior (AP) and cross-table lateral digital radiographs for each patient were obtained. The AP radiograph was measured using Hip Analysis Suite to calculate the cup abduction and version angles (version direction determined separately). Acceptable ranges were 35–45° for abduction, and 5–20° for version. Correlations were then determined with SPSS™ software.

Results: There were 1980(96%) qualifying patients. There were 1025(52%) acetabular cups that fell within the 35–45° abduction range, and 1287(70%) cups in the 5–20° version range. Regression analysis showed that the only independent predictor of acceptable abduction angle was the surgical approach (p< 0.001). Posterolateral approach was the most accurate (57% acceptability). In contrast to the posterolateral, the MIS (2 incision) approach was 3 times (95%C.I. 1.5–5, p=0.001), and the mini anterolateral approach 2.5 times (95%C.I. 1–6.5, p=0.035) more likely to have unacceptable abduction angles. The only independent predictor of acceptable version was the performing surgeon (p< 0.001), with higher volume surgeons showing greater accuracy.

Conclusion: The posterolateral approach was superior to MIS (2 incision) and mini anterolateral approaches for acceptable abduction angle, and surgeon volume influenced version angle acceptability. Further analysis on variables and their influence on cup position at a lower volume medical center would provide a valuable comparison.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_II | Pages 223 - 223
1 May 2011
Wannomae K Rowell S Micheli B Malchau H Muratoglu O
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Radiation crosslinking decreases the wear of ultra-high molecular weight polyethylene (UHMWPE) and subsequent heating increases its oxidative stability. Clinical trials are showing lower femoral head penetration rate with highly crosslinked vs. conventional UHMWPE liners. Recently, a follow-up report showed a surprising increase in the femoral head penetration rate with a highly crosslinked UHMWPE, prompting us to closely analyze surgically explanted highly crosslinked UHMWPEs.

Thirty-four highly crosslinked components, all irradiated (100kGy) and melted, were included in the study. The components were surgically removed from patients for non-polyethylene related reasons. Oxidation was determined at the rim immediately after explantation. After shelf storage in air for 5–77 months, oxidation and crosslink density were measured at the rim and articular surfaces. An additional retrieval (92 mos. in vivo) was tested on the hip simulator; oxidation and crosslink density were determined after simulator testing.

All components showed no detectable oxidation immediately after explantation; however, surprisingly oxidation levels increased during shelf storage. Areas with increased oxidation showed a decrease in crosslink density. These changes did not correlate with in vivo duration; however, they correlated strongly with ex vivo duration. The component subjected to hip simulator testing showed no measurable wear and showed no detectable oxidation or marked decrease in crosslink density.

Two mechanisms may have reduced the oxidation resistance of highly crosslinked UHMWPE upon exposure to in vivo elements and subsequent exposure to air. One mechanism is based on free radical formation during cyclic loading; the other is based on an oxidation cascade initiated by absorbed lipids. Further studies are necessary to determine the impact of these mechanisms, if any, on the stability of components during in vivo service.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_II | Pages 88 - 89
1 May 2011
Malchau H Callanan M Bragdon C Zurakowski D Jarrett B Rubash H
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There are a variety of patient and surgical factors shown to increase post-operative complication risk for a total hip arthroplasty (THA). While many studies have linked patient and surgical factors to unsuccessful outcomes post total hip arthroplasty (THA), no study has attempted to correlate the infiuence of these factors to the positioning of the acetabular cup. The purpose of this study was to determine if a correlation exists between patient and surgical factors and the anatomical position of the acetabular component.

Data for 2063 patients from 2004–2008 who underwent a primary total hip arthroplasty (THA), revision THA, or Birmingham Hip Resurfacing procedure was compiled. The post- op anteroposterior pelvis (AP) and the cross table lateral digital radiographs for each patient were measured to determine cup inclination and version. Acceptable angle ranges were defined as 30–45° for abduction, and 5–25° for version. Correlations between variables and cup abduction and version angles were determined with SPSS™ statistical software.

There were 1954(95%) qualifying patients. There were 1218(62%) acetabular cups that fell within the 30–45° optimal abduction range, and 1576(87%) cups in the 5–25° optimal version range. There were 921(47%) patients that had both inclination and version angles that fell within the optimal range. Regression analysis showed that surgical approach (p> 0.001), high/low volume surgeon (p< 0.001), and obesity (BMI > 30, p=0.01) were independent predictors for abduction and version combined analysis. Both surgical approach (p< 0.001) and BMI (p=0.018) were independent predictors in the individual analysis of both abduction and version. High/low volume surgeon was significant for the independent analysis of abduction (p=0.013). In the combined analysis, low volume surgeons showed a 2 fold increase (95% C.I. 1.5–2.8) in risk for cup malpositioning compared to high volume surgeons. The MIS surgical approach showed a 6 fold increase (95% C.I. 3.5–10.7) in risk for cup malpositioning compared to the posterolateral approach. Obesity (BMI> 30) showed a 1.3 fold increase (95% C.I. 1.1–1.7) in risk for cup malpositioning compared to all other body mass index groups.

Posterolateral surgical approach was superior to MIS surgical approaches for independent and combined abduction and version analysis. High volume surgeons had greater accuracy for cup positioning, specifically for achieving optimal cup abduction angle. Compared to all other body mass index categories, patients that were obese (BMI> 30) displayed a greater risk for cup malpositioning for independent and combined abduction and version analysis. Further statistical analyses on patient and surgical variables and their infiuence on cup position at a lower volume medical center would provide a valuable data comparison.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_II | Pages 126 - 126
1 May 2011
Bragdon C Martell J Clohisy J White R Goldberg V Della Valla C Berry D Jarrett B Harris W Malchau H
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Studies of patients having primary THR using highly cross-linked polyethylene show excellent clinical outcomes and very low radiographic wear results at a minimum of 5 years follow-up. Recently, a radiostereometric analysis (RSA) study of a small group of patients reported that after no detectable wear during years 1–5, they found a significant increase in femoral head penetration between 5 and 7 years follow-up. However, this increase in head penetration after 5 years has not been confirmed in a larger patient cohort.

The purpose of this study was to organize a multicenter radiographic study involving leading medical centers in the U.S. having the longest-term follow-up available on this type of highly cross-linked polyethylene in order to determine if the RSA observation can be confirmed in a larger study.

Six academic centers agreed to contribute radiographic data to this study. All patients received primary total hip replacements with Longevity polyethylene liners (Zimmer, Warsaw, IN) coupled with 26, 28, and 32mm cobalt chrome femoral heads. The radiographic inclusion criteria required a minimum of four radiographs per patient: one at 1 year; at least one from 2 to 4.5 years; one 4.5 to 5.5 years; and at least one from 5.5 to 9 years follow-up. The Martell Hip Analysis Suit-eTM software was used for the wear analysis. All wear values were determined by calculating head penetration between the follow-up radiograph and the 1-year radiograph to remove creep, the majority of which has been shown to occur during the first year. Separate linear regressions, representing the wear rates, were computed for the early period from 1 year to 5.5 years and the late period from 5.5 years to 9 years follow-up. The Zar test was used to determine the significance of the difference between these two linear regressions.

We present the completed analysis of 165 hips. When the early and late data points were combined into one data set, the second-order regression indicated an inflection point at 6.3 years with a slightly positive inflection. There were 402 film comparisons in the early time period, and the slope and confidence interval of the regression line was 4.9μm/yr (95% CI of −28μm/yr to 38μm/yr). There were 188 film comparisons in the late period, and slope of the regression line for the late period was 10.8 μm/yr (95% CI of −58μm/yr to 80μm/yr). The Zar test showed no significant difference between the two slopes (Figure 1, p=0.886).

No significant increase in femoral head penetration was found for the late period after 5 years compared to the early period before 5 years follow-up in either analysis. Additionally, no significant late increase in wear was seen within individuals. While we continue to enroll patients, at this time we do not observe the increase in wear seen in the RSA study after 5 years.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_II | Pages 197 - 197
1 May 2011
Ostendorf M Malchau H Kärrholm J Dhert W Eisler T
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Of 960 first-revision total hip replacements (THR) because of deep infection identified in the Swedish Hip Arthroplasty Registry, 16.9% were treated with a permanent implant extraction, while a staged or direct reconstruction revision protocol were employed in 56.2% and 26.9% respectively. The majority of the interventions were performed more than one year after index THR, and the dominating pathogen was coagulase negative staphylococci (CNS). We found a significant shift in types of bacteria over the years (Chi-square test, p smaller than 0.001): an increase in the CNS group and a decrease in Gram-negative aerobes. Patients treated with a permanent resection were generally older (p< 0.001), had more often a previous ipsilateral hip fracture (p< 0.001), and had more frequently Gram-negative infections (p=0.02). No systematic differences in patient characteristics or pathogens were detected between one-stage or two-stage procedures, of which the latter had a median re-implantation time of 2 (range: 0.2–62) months. Of 798 (one- or two-stage) revisions, 60 (7.5%) were revised again due to recurrent infection, with no difference between the two methods, and implying a 10-year survival of 90%; 95% confidence interval (CI95%) 88.2–93.0. Previous surgery for soft-tissue problems (RR 3.2 (CI95% 1.3–7.2)) predicted a worse outcome for one-stage procedures. The prognosis of two-staged revisions improved with increasing re-implantation interval (RR 0.8 (CI95% 0.7–1.0)) per month, and a 6 month interval carried the lowest risk of repeat revision due to infection; RR 0.1 (CI95% 0.0–0.9). Staged revisions in female patients (RR 2.3, (CI95% 0.9–5.7)) and with Staphylococcus aureus infections (RR 2.3 (CI95% 0.9–5.5)) predicted a worse outcome. Ten-year survival with repeat revision for aseptic loosening as end-point was 89% (95%CI 85.7–92.0), but decreased to 79% when all reasons for revision were taken into account (95%CI 75.0–82.3) mainly because of revision for peri-prosthetic fractures.

The results suggest that direct and staged revision protocols can have a good prognosis on a national level, but efforts must be made to counteract periprosthetic fractures and the high incidence of permanent implant extraction in elderly patients.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 514 - 514
1 Oct 2010
Fehm M Burke D Geller J Huddleston J Malchau H
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Background: Abductor failure after total hip arthroplasty is a rare but debilitating problem. The diagnosis is difficult, and when recognized, there are few successful treatment options. The purpose of this study is to review our experience with a new surgical technique using fresh-frozen Achilles tendon allograft with an attached calcaneal bone graft to reconstruct a deficient abductor mechanism after total hip arthroplasty.

Methods: From 2003 to 2006, we performed seven abductor reconstructions with Achilles tendon allograft for patients with abductor deficiency after total hip arthroplasty. Four patients had a prior posterior approach and three had a prior anterolateral approach. At a mean of 29 months from index procedure, all seven patients suffered from symptoms of lateral hip pain and abductor weakness as documented by positive Trendelenburg sign, limp, and limited motor strength with side-lying abduction. Hip arthrograms were obtained in five of seven patients.

Results: The average pre-reconstruction Harris Hip Score was 34.7 and average pain score was 11.4. All five hip arthrograms showed extravasation of dye over the greater trochanter, confirming the diagnosis of a bald greater trochanter and massive abductor loss found at time of surgery. At a minimum 24 month follow-up and an average follow-up of 31 months, the post-reconstruction Harris Hip Score was 85.9 and the average pain score was 38.9.

Conclusions: Abductor reconstruction with Achilles tendon allograft using calcaneal bone block fastened to the greater trochanter has offered significant relief of pain and improvement in function at early follow-up in this series of patients.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 520 - 520
1 Oct 2010
Jibodh S Bragdon C Greene M Kandil A Malchau H
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Highly cross-linked polyethylene liners in total hip replacement (THR) have allowed the use of larger diameter femoral heads. Larger heads allow for increased range of motion, decreased implant impingement, and protection against dislocation. The purpose of this study is to report the clinical and radiographic outcomes of patients with large femoral heads with HXLPE at 5 years post-op.

A group of 124 patients (132 THRs) who had a primary THR with a 36mm or larger cobalt-chrome femoral head and a Durasul or Longevity liner (Zimmer; Warsaw, IN) were prospectively enrolled in this study. 93 THRs (88 patients) had minimum 5 year follow-up. All patients received a cementless acetabular shell (Trilogy or Inter-op, Zimmer Inc, Warsaw IN) and a highly cross-linked polyethylene liner with an inner diameter of 36 or 38mm. The median radiographic follow-up was 5.6 years (range 5.0–8.0), and patients were assessed clinically by Harris Hip score, UCLA activity score, EQ-5D, and SF-36 functional scores. Femoral head penetration was measured using the Martell Hip Analysis Suite.

No osteolysis was seen in the pelvis or proximal femur, and no components failed due to aseptic loosening. Four patients have questionable signs of bone changes around the acetabular shell with future CT scans scheduled to help reach a final determination. The median acetabular shell abduction and anteversion were 44° (30–66°) and 13° (3–33°) respectively. There was no evidence of cup migration, screw breakage, or eccentric wear on the liner. Regarding the femoral component, there were no episodes of loosening, migration, osteolysis, or fracture. There was no significant difference in the median penetration rate from post-op to longest follow-up between the 36mm (24 patients) and 38mm (4 patients) femoral head groups (0.056±0.10mm/yr and 0.060±0.05mm/yr respectively). Therefore, the data were pooled into one group. Using every post-op to follow-up comparison, the linear regression penetration rate of this combined group was 0.003 mm/yr which is within the error detection of the Martell method. The median femoral head penetration rate during the first post-op year measured 0.59±1.04 mm/yr. In contrast, the median steady state wear rate from the 1yr film to the longest follow-up measured -0.009±0.15mm/yr. A linear regression steady state wear rate from the 1 year film to every follow-up of −0.031 mm/yr indicated no correlation between the magnitude of polyethylene wear and time.

The mid-term results on this series of patients with THRs with a 36 or 38mm femoral head articulating with highly cross-linked polyethylene showed excellent clinical, radiographic, and wear results. The lack of early signs of osteolysis with the use of these large diameter femoral heads is encouraging. Continued and longer-term follow-up is needed to provide survivorship data.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 511 - 511
1 Oct 2010
Bragdon C Burke D Ekeledo A Freiberg A Greene M Harris W Malchau H
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Highly cross-linked polyethylene (HXLPE) is one of the most widely utilized bearing surfaces for total hip arthroplasty (THA). The first patients to receive XLPE will be 10 years post-op as of December 31, 2008. The purpose of this study is to report the long-term clinical and radiographic outcomes of patients implanted with HXLPE.

A group of 247 primary total hip replacements (224 patients) using HXLPE liners (Longevity or Durasul, Zimmer Inc.) with 22, 26, 28, or 32mm femoral heads were implanted between 1999 and 2001. Clinical evaluation measures included the Harris hip, EQ-5D, SF-36 functional scores, and UCLA activity scores. In addition to plain radiograph assessment, the computerized Martell method was used to measure head penetration over time. A matched group of 241 primary total hip replacements (201 patients) with the same head sizes using conventional polyethylene (PE) with a minimum of 7 years follow-up was used as a Martell method control group. The steady state penetration rate was defined as the slope of the linear regression line of the plot of head penetration from the 1 year film to each subsequent film to discount the early bedding-in process. A student’s t-test was used to compare wear rates between head sizes in each group, and a repeated-measures mixed model ANOVA was used to compare the groups for the 28mm head size.

There were no osteolytic lesions around the cup or stem, and no revisions were performed for polyethylene wear or liner fracture. Clinical outcome scores were averaged: Harris Hip 88.1±11.97, EQ-5D 74.0±27.0, SF-36 physical activity scores 53.3±8.4, SF-36 mental score 46.9±11.1, and UCLA activity 6.4±2.1. The steady state wear of the conventional polyethylene patients increased with time for both 26 and 28mm head sizes (0.144 and 0.127mm/year, respectively). No significant difference was found between the head sizes coupled with conventional polyethylene (p=0.14). Femoral head penetration in the highly cross-linked polyethylene did not increase over time after the first year. The steady state wear rates of HXLPE liners with 28mm or 32mm femoral heads were not significantly different than a slope of zero (p=0.54 for both head sizes).

Clinical follow-up results are typical of a primary THR patient population, and the radiographic results are excellent with no signs of peri-prosthetic osteolysis. Patients with PE show wear rates that are significantly different than zero indicating significant wear of the material. Conversely, patients with HXLPE display no measureable wear at 7–9 years as the wear rates were within the error detection of the Martell method. This long-term clinical and radiographic follow-up study for this new bearing material shows excellent clinical outcomes with very low in vivo wear.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_II | Pages 310 - 310
1 May 2010
Rolfson O Dahlberg L Nilsson J Malchau H Garellick G
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Objective: The Charnley grading system (A, B, C) has previously been shown to be a valid predictor concerning outcome after joint replacement surgery. In this study we hypothesized that anxiety/depression, one of five dimensions in the health related quality of life measurement tool EQ-5D, could predict the outcome after total hip replacement surgery.

Methods: Data from the Swedish Hip Arthroplasty Register including 6 158 patients with primary osteoarthritis were analysed. To examine the association of anxiety with respect to the outcome of pain (VAS) and satisfaction (VAS) a general linear regression model was used.

A subgroup of 481 patients in the Western Region of Sweden with complete data on individual CPP (cost per patient) was selected for the health economic analysis.

Results: The preoperative EQ-5D anxiety/depression dimension was a strong predictor for pain relief, patient satisfaction, and cost-effectiveness with surgery. Patients with comorbidity (Charnley category C) had a significant worse outcome with regards to pain relief, satisfaction and EQ-5D index scores than patients in Charnley category A and B (p< 0.001). Females generally had worse outcome scores than males in all three outcome measurements (p< 0.001).

Conclusion: Orthopaedic surgeons involved with the care of patients eligible for THR surgery should be alert to the fact that mental health may influence pain-experience and HRQoL outcome. Appropriate assessment of mental health may enable us to modify the approach in which we manage these patients, in order to optimize the outcome following joint replacement surgery.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_II | Pages 295 - 295
1 May 2010
Bragdon C Greene M Goldvasser D Freiberg A Malchau H
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Introduction: Electron beam irradiated highly cros-slinked polyethylene has been used in total hip arthroplasty for over 8 years. Due to its low wear characteristics, the use of femoral heads that are greater than 32mm in diameter is now available, allowing for an increase in range of motion and increased stability against dislocation when necessary. The purpose of this study is to provide a summary report on the radiographic analysis of the longest term data available on primary THR patients receiving highly cross-linked polyethylene and to compare the results of two methods of measuring femoral head penetration.

Methods: Three prospective clinical studies involving electron beam irradiated highly cross-linked polyethylene have been initiated at our center. To date, the results of: 200 hips with a minimum of 6 year follow-up with conventional sized femoral heads (primarily 28 and 32mm); 45 hips with minimum 5 year follow-up with larger sized femoral heads (primarily 36 and 38mm); and 30 hips with 5 year follow-up enrolled in a Radiostereometric analysis (RSA) study (15 patients with 28mm and 15 patients with 36mm diameter femoral heads); were available for this summary report. Data from patient administered questionnaires (Harris Hip score, UCLA activity score, and WOMAC), radiographic review, and wear analysis using RSA or the Martell Hip Analysis Suite™. In addition, for comparative purposes, wear was measured in a subset of patients using the Devane Polyware™ program.

Results: All hips had good clinical outcome at longest follow-up regardless of which femoral head size was used. There were no revisions due to polyethylene wear and no evidence of peri-prosthetic osteolysis. In general, after the bedding in period, there was no significant increase in femoral head penetration regardless of head size.

For RSA, the wear rate for the 28mm femoral head group was 0.05±0.02 while the 36mm femoral head group was 0.03±0.02, p=0.13.

For the Martell analysis, the average steady-state wear rate was −0.002 ± 0.01 mm per year and −0.026 ± 0.13 mm per year for 28mm and 32mm head sizes, respectively, p=0.62. There was no correlation between wear and time in situ or femoral head size for any of the clinical studies.

In comparing the Martell and Devane programs, the total average wear rates were significantly different, 0.07±0.05 and 0.03±0.06mm/year respectively, p=0.01. However, when the absolute values of the Martell results were used, there was no difference, p=0.22.

Conclusion: The mid-term follow-up of a large group of primary THR patients receiving highly cross-linked polyethylene components have shown no problems related to the new bearing material. Extremely low wear and lack of peri-prosthetic osteolysis are encouraging results requiring further long-term study.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_II | Pages 323 - 324
1 May 2010
Malchau H Slover J Bozic K Tosteson A Rubash H
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Background: The rates of primary and revision knee arthroplasty in the United States have been increasing. Simultaneously, several studies have reported increased complication rates when these procedures are performed at low-volume centers. One innovation designed to improve knee arthroplasty outcomes is computer navigation, which aims to reduce revision rates by improving the alignment achieved at surgery. The purpose of this study was to examine the impact of hospital volume on the costeffectiveness of this new technology in order to determine its feasibility and the level of evidence that should be sought prior to its adoption.

Methods: A Markov decision model was used to evaluate the cost-effectiveness of computer-assisted knee arthroplasty, in relation to hospital volume. Transition probabilities were estimated from the arthroplasty literature, and costs were based on the average reimbursement for primary and revision knee arthroplasty at out institution. Outcomes were measured in quality adjusted life years.

Results: The results demonstrate that computer-assisted surgery becomes less cost-effective as the annual hospital volume decreases, as the cost of navigation increases, and as the impact on revision rates decreases. If a center performs 250 cases per year, computer navigation will be cost-effective if the annual revision rate is reduced by 2% per year over a twenty-year period. If a center performs 150 cases per year, computer navigation is cost-effective if it results in a 2.5% reduction in the annual revision rate over a twenty-year period. If a center performs only 25 cases per year, the annual reduction in revision rates must be 13% for computer navigation to be cost-effective.

Conclusion: This analysis demonstrates that computer navigation is not likely to be a cost-effective investment in health care improvement in low volume joint replacement centers, where its benefit is most likely to be realized. However, it may be a cost-effective technology for higher volume joint replacement centers, where the decrease in the rate of knee revision needed to make the investment cost-effective is modest, if improvements in revisions rates with the use of this technology can be realized. This illustrates that hospital volume can have a substantial impact on the cost-effectiveness of new technology in surgery, and this should be carefully considered by any center considering such a large capital investment.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_III | Pages 447 - 447
1 Sep 2009
Thien T Malchau H Herberts P Kärrholm J
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In a previous report from a randomised study we reported excellent fixation and less proximal periprosthetic bone mineral loss around the Epoch design at 2 years follow-up when compared with a solid stem of similar design. We now present the 7 years follow-up.

Forty consecutive patients (20 men, 10 women, mean age 57, 41–74) with non-inflammatory osteoarthritis were randomised to receive either a cementless porous-coated composite stem with reduced stiffness (Epoch) or a cementless stiff stem with a porous coating (Anatomic). Patients were followed for 7 years with repeated evaluations using radiostereometry, DXA, conventional radiography and Harris Hip Score (HHS).

At 7 years 1 stem had been revised (Anatomic) due to late infection. Subsidence and stem rotations were close to zero without any difference between the two groups (p> 0,12). Median wear rates were lower than expected (0.4mm up to 7 years) for both stem designs. At 2 years loss bone mineral density was less in Gruen regions 1, 2, 6 and 7 for the Epoch stems (p< 0.04), but this difference tended to disappear with time. At 7 years only the calcar region (Gruen region 7) had significantly denser bone in the Epoch group (p< 0.001). The HHS scores did not differ (median 98, 51–100). No stem was radiographically loose.

The Epoch stem achieved excellent fixation. Wear rates were low despite use of conventionally gamma-sterilised polyethylene. This low modulus stem had positive effects on early proximal bone remodeling, but this effect decreased with time.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 35 - 35
1 Mar 2009
Kurtz S Lau E Havelin L Dybvik E Ong K Malchau H
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Starting in the 1970s, long-term survivorship of total hip and knee arthroplasty has been under investigation for the Scandinavian population with the aid of implants registries. In the United States, no national arthroplasty registry currently exists. Nationwide inpatient discharge databases in the United States have proven useful when comparing the revision burden in the United States and Scandinavia. For this study, we compared the implant survivorship in the Medicare population with contemporaneous registry-based data from well-established and validated Scandinavian arthroplasty registries. The 5% systematic sample of Medicare claims from 1997 to 2004 were examined for primary and revision THA and TKA claims. The Medicare beneficiary ID was used to follow patients longitudinally between primary and revision surgery. De-identified data from the Norwegian and Swedish national hip and knee registry were also obtained for the same time period. During the 8-year study period, 30,583 and 62,878 elective primary total hip or knee replacements, respectively, were extracted from the Medicare data. In the same time period, 41,823 and 15,927 primary total hips or knees replacements were identified from the Norwegian registry. 82,037 primary total hips were identified from the Swedish registry. Survivorship was assessed by the Kaplan-Meier method, and Cox regression was used to evaluate the effect of patient attributes and cross-country comparisons. The K-M estimate showed that 8 years post-primary surgery, 93.6% of THA and 96.2% of TKA remained revision-free among the elderly Medicare population. By comparison, among Norwegians aged 65 and above, 96.0% of THA and 93.6% of TKA remained revision-free. In the US, men had a significantly higher risk of knee revision than women, but no significant gender difference among hip revision. In Norway, men had a significantly higher risk of hip revision, but no differences in knee revisions. In Sweden, men had a significantly higher risk of hip revision (5.4% vs. 3.3%). Older patients had a reduced risk of revision as compared with younger patients, in both the US and in Norway. The survival of THA is significantly better in Norway than in the US with a hazard ratio of 1.64 (p< 0.05). On the other hand, TKA had a better survival experience in the US than in Norway, with a hazard ratio of 0.55 (p< 0.05). This is the first study to evaluate the utility of Medicare as a source of THA and TKA survivorship data and to compare prosthesis outcomes in Medicare with those from Scandinavian arthroplasty registries. Unlike the Norwegian and Swedish registry data, the reasons for revision (e.g., femoral loosening) are not captured and thus greatly limited the value of the Medicare data as a tool to understand the need for revision, thereby helping to improve implant longevity and to reduce the associated cost and burden to the patient and care provider.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 106 - 106
1 Mar 2009
Lindahl H Malchau H Garellick G Herberts P
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INTRODUCTION: The postoperative periprosthetic femoral fracture is a severe complication after total hip surgery. It has become the third most common reason for revision. Three-hundred and twenty one fractures operated during 1999–2000, were followed in a prospective nationwide study. The study focused on the failure rate, patient satisfaction, treatment and radiographic evaluation.

PATIENTS AND METHODS: During 1999–2000, 230 fractures after a primary THR and 91 after a revision THR were reported to the Swedish National Hip Arthroplasty Register. All hospital records were collected. At follow-up the Harris hip score, a health-related quality of life measure (EQ-5D) and patient satisfaction were used as outcome measurement. A radiologist performed the radiographic evaluation.

RESULTS: A high number of patients had a loose implant at fracture time (66% in the primary group and 51% in the revision group). Eighty-eight percent of the fractures were classified as Vancouver type B fractures. A major finding was the association between the type of implant and the risk of a periprosthetic fracture. The Charnley and the Exeter prostheses were significantly over represented among patients with fractures and the Lubinus prosthesis significantly under represented. The surgeons grading of the Vancouver type B1 fracture was not in agreement with the study radiologist in more than 34% of the cases. Patient’s satisfaction concerning mobility, self-care, normal activities, pain and anxiety compared to an age matched population with a THR were poor. There was a high failure rate and by December 31, 2004, 22% had been reoperated.

DISCUSSION: A recommendation is to follow all THR patients with regularly radiographic monitoring and to intervene before the fracture. Implant related factors have to be considered when choosing implant for routine use. Difficulty in evaluating the x-rays concerning the stability of the prostheses might lead to sub optimal treatment. We recommend exploration of the implant for all patients with a Vancouver type B fracture if there is any doubt about the fixation status.


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 2 | Pages 157 - 161
1 Feb 2009
Rolfson O Dahlberg LE Nilsson J Malchau H Garellick G

In this study we hypothesised that anxiety/depression, one of five dimensions in the health-related quality of life (HRQoL) measurement tool EQ-5D, could predict outcome after total hip replacement surgery.

Pre-operative and one-year post-operative data from the Swedish Hip Arthroplasty Register, including 6158 patients with primary osteoarthritis of the hip, were analysed. In order to examine the association between anxiety and outcome with respect to pain and satisfaction an analysis of covariance was used.

The pre-operative EQ-5D anxiety/depression dimension was a strong predictor for pain relief and patient satisfaction (p < 0.001).

Orthopaedic surgeons involved in the care of patients eligible for total hip replacement surgery should be aware that mental health may influence post-operative pain and HRQoL. An appropriate assessment of mental health may enable a modification in the way these patients are managed in order to optimise the outcome after joint replacement surgery.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 45 - 45
1 Mar 2006
Digas G Kärrholm J Thanner J Malchau H Herberts P
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Introduction: The annual wear rate in polyethylene articulations should be 0.1 mm or less to avoid future osteolysis. Highly Crosslinked polyethylene demonstrates 80–90% wear reduction in hip simulator testing, but the clinical documentation of this new polyethylene is still inadequate. We evaluated the highly crosslink PE in two prospective randomised clinical studies. Patients and Methods: Thirty two patients (12 male, 20 female, 64 hips) with a median age of 48 years (range, 29–70 years) with bilateral primary or secondary arthrosis of the hip received hybrid THA. With liners made of highly cross-link on one side and conventional PE on the other one. Twenty-seven patients in this study have passed 2 years follow up. Further Sixty patients (61 hips) with a median age of 55 years (range, 35–70 years) were randomized to receive either highly crosslink or conventional cemented all PE of the same design. Forty-nine patients have been followed for 3 years. In both studies all patients received Spectron stems with 28mm cobalt-chromium head. Radiostereometric examinations with the patient supine or standing were done at regular intervals. Wear was measured in the supine position from the postoperative week, whereas standing examinations were initiated three months after the operation. Results: The penetration rate was almost identical in the study and control groups in 6 months after the operation. Thereafter the penetration rate levelled out in the 2 groups with highly crosslink PE. At two years the highly crosslink PE liner showed 62% lower proximal penetration and 31% lower total (three-dimensional) penetration when the patients were examined in supine position. The highly crosslink all PE cemented cups showed significantly lower proximal penetration in both position. Discussion: The better wear performance of highly crosslink PE could increase the implant longevity. Longer follow up is needed to evaluate if this new material is associated with less occurrence of osteolysis.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 47 - 48
1 Mar 2006
Hilmarsson S Soderman P Herbert P Malchau H
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Objectives. The Swedish National Total Hip Arthroplasty Register, initiated in 1979, describes the epidemiology of total hip replacement (THR) in Sweden. The objective of this study was to describe the epidemiology, demographics and to perform an outcome analysis on patients, younger than 55 years, who underwent a total hip replacement in Sweden between 1992–2002. Methods. From the Swedish National Total Hip Arthroplasty Register 11579 patients, younger than 55 years at the time of surgery, were identified who had undergone a primary total hip replacement from 1992–2002. The patients selected were checked with the Swedish Cause of Death Register (CDR), based on the unique identification number used in Sweden, to ensure that only living patients were addressed. Epidemiological and demographical analysis was then performed using SPSS (SPSS Inc, Chicago, IL). Outcome. 11362 patients were identified. 5260 (46,3 %) men and 6102 (53,7 %) women, the mean age was 48, 2 years (14–55). The indication for surgery was in over 60% of the cases Osteoarthrosis (OA) but over-represented diagnosis, when compared to the remaining THR operations in Sweden, were arthritis, osteonecrosis and sequele after childhood disease. The most common fixation technique used was cemented total hip replacement in 6160 (54,2 %) followed by Hybrid 2442 (21,5 %) and uncemented 2235 (19,7 %) technique. Survival for cemented, uncemented and hybrid implants in male patients with Osteoarthrosis after 10 years was 65,8 % (+/− 2,6%), 66,6 % (+/− 2,9%) and 64,0 % (+/− 3,0 %) respectively. In the arthritis group the survival was slightly better with a 10 year survival of 72,8 % (+/− 3,6%), 66,8 % (+/− 5,9%) and 71,5 % (+/− 7,5%) respectively, male patients had a slightly inferior outcome compared to females across all diagnosis groups. Conclusions. This young cohort is epidemiologically and demographically different than the older one previously studied in the Swedish National Hip Register. Survival analysis shows that 10 year survival in this population is considerably worse than for the older cohort. Patients with arthritis fare better than patients with Osteoarthrosis and females have superior outcome to males. In this study the mode of implant fixation did not appear to influence survival in patients with OA, however it does seem to affect the outcome in patients with inflammatory arthritis. This study shows that the outcome in this patient category is poor when compared with the older THR patients. There is an obvious need to increase use of alternative and conservative methods in treatment of the young patient with degenerative hip disease. Continuous research and referral of the young patients to dedicated centres is recommended.


The Journal of Bone & Joint Surgery British Volume
Vol. 88-B, Issue 1 | Pages 26 - 30
1 Jan 2006
Lindahl H Malchau H Odén A Garellick G

Periprosthetic fracture of the femur is an uncommon complication after total hip replacement, but appears to be increasing. We undertook a nationwide observational study to determine the risk factors for failure after treatment of these fractures, examining patient- and implant-related factors, the classification of the fractures and the outcome.

Between 1979 and 2000, 1049 periprosthetic fractures of the femur were reported to the Swedish National Hip Arthroplasty Register. Of these, 245 had a further operation after failure of their initial management. Data were collected from the Register and hospital records. The material was analysed by the use of Poisson regression models.

It was found that the risk of failure of treatment was reduced for Vancouver type B2 injuries (p = 0.0053) if revision of the implant was undertaken (p = 0.0033) or revision and open reduction and internal fixation (p = 0.0039) were performed. Fractures classified as Vancouver type B1 had a significantly higher risk of failure (p = 0.0001). The strongest negative factor was the use of a single plate for fixation (p = 0.001). The most common reasons for failure in this group were loosening of the femoral prosthesis, nonunion and re-fracture.

It is probable that many fractures classified as Vancouver type B1 (n = 304), were in reality type B2 fractures with a loose stem which were not recognised. Plate fixation was inadequate in these cases. The difficulty in separating type B1 from type B2 fractures suggests that the prosthesis should be considered as loose until proven otherwise.


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_III | Pages 242 - 242
1 Mar 2004
Digas G Kärrholm J Thanner J Malchau H Herberts P
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Aims: The aim of this study was to evaluate a highly cross-linked polyethylene WIAM in cemented hip arthroplasty. This new polyethylene has been resistant to wear in laboratory tests. Methods: 60 patients (30 women, 30 men) with a median age of 55 years (35–70) and a median weight 82 kg (47–120) were included. All patients received a Spectron femoral stem with a 28 mm head in chrome-cobalt. The patients were randomised to acetabular cups made of either WIAM (electron beam irradiation 9.5 Mrad) or conventional polyethylene (CP) sterilized in inert atmosphere. Radiostereometric examinations (supine) were done 7 days after the operation and after 3, 6 12 and 24 months. Examinations (standing) were performed at 3, 6 12 and 24 months. The migration of the femoral head centre in relation to the polyethylene marker represented the femoral head penetration. Results:. 43 hip (19 WIAM 24 CP) were available for 24 months FU. There were no differences in cup migrations between the two groups. The mean proximal penetration (supine and standing) was less than 0.2 mm at 24 months in both groups p> 0,06 Conclusions: The femoral head penetration during the first two years may be dominated by creep. There is tendency for lower proximal penetration at standing examination in the WIAM group. Futher studies and longer follow up is necessary until highly crosslink polyethylene can be recommended for general use.


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_III | Pages 217 - 217
1 Mar 2004
Herberts P Malchau H
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Aims: In 1979 a national observation study of total hip arthroplasties was started in Sweden. The Swedish Hip Register describes the epidemiology of primary and revision surgery and identifies risk factors for failure. Every unit reports details concerning implants, surgical and cementing technique and revision procedures online via the Internet home page (www.jru.orthop.gu.se). Methods: Currently the register contains 203 625 primary total hip arthroplasties performed during 1979–2001 and 18 067 revision procedures. Revision is the failure endpoint definition and modified Kaplan-Meier statistics and Poisson models are used for survival analysis. Each hospital receive their results annually providing a system for continuous improvement. Results: The results show that serious complications have declined significantly despite an increasing number of patients at risk. The revision burden for cemented THR (94% of the implants are cemented) is only 7.5%, which is much lower than in other countries. Over the 22 year period revision for aseptic loosening has been reduced to one quarter. Demographics are important since male gender and young age significantly increase the risk for revision. Cementless implants have in general had a worse outcome than expected but improved during the last decade. Conclusion: Problem areas are the young population and revision surgery which must be improved. The revision burden is about two times higher in all other countries. This finding implies that the register is extremely cost-effective and the reduction in direct costs for the health care service in Sweden corresponds to approximately USD 140 millions over the last ten years.


Orthopaedic Proceedings
Vol. 85-B, Issue SUPP_III | Pages 202 - 202
1 Mar 2003
Devane P Horne J Hauser-Kara D Martell J Malchau H Harris W
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The purpose of this study was to compare the 2D and 3D linear and volume wear readings of the three most commonly used methods for measuring polyethylene wear: the Livermore, Devane and Martell techniques. Inter-observer variation of measurements using the techniques of Devane and of Martell on conventional radiographs was also performed. The radiographs of 80 patients (mean age 60+/−10 yrs) who had a Harris-Galante I total hip arthroplasty were measured. Nine different reviewers for the Devane technique readings including Dr Devane and eight reviewers for the Martell technique readings including Dr Martell made blinded independent wear observations for each radiograph set. One reviewer measured the 20 annual linear wear rate for all radiograph sets using the 2D Livermore technique. Inter-observer variation as a function of patient, reviewer, and total variation was statistically assessed using variance component analysis. Mean wear measured using the Livermore technique was the same as with the Devane and Martell method, but with a greater variation. Comparison of the Devane and Martell method for patient STD, reviewer STD, error STD (multiple reviews of same radiographs), total STD (randomly picked reviewer), mostly show a mean 50% lower STD with the Devane technique. Correlation (correlation coefficient of two randomly selected reviewers) is significantly better with the Devane technique.


Orthopaedic Proceedings
Vol. 84-B, Issue SUPP_III | Pages 255 - 255
1 Nov 2002
Malchau H Kärrholm J Thanner J Herberts P
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Introduction: In a pioneer study Oonishi et al (1988) found reduced socket wear with the use of polyethylene subjected to high radiation doses. This observation has stimulated the development of a new generation polyethylene. In addition to high radiation doses the plastic is also subjected to various types of heat treatment to reduce the amount of free radicals. The purpose of the present study is to evaluate one of the new highly cross-linked polyethylenes in a randomized controlled study of cemented THA. The hypothesis is that the improved wear resistance will reduce the prevalence of osteolytic lesions with long-term follow-up.

Methods and materials: Patients in clinical and radiographic need of a THR with non-inflammatory osteoarthritis of the hip were randomized in two groups. Group 1 received a cemented Weber cup (Sulzer®, Switzerland) made of highly cross-linked (WIAM) polyethylene, group 2 got a conventional cup. All patients received a cemented Spectron (Smith & Nephew, USA) with a 28mm cobalt-chromium head.

So far 15 patients, (6 male and 9 females) with a median age of 55 years (range 42–62) have been evaluated in group 1 and 14 (9 male and 5 females) with a median age of 55 years (range 45–70) in group 2. The penetration of the femoral heads has so far been measured postoperatively (all hips supine), after 3 month (17 hips supine and standing) and after 6 month (11 hips supine and standing) using radiostereometry.

Results: The median proximal and three-dimensional (3-D) penetration (total wear) 0–6 month (supine position) was almost equal in the two groups. Group 1 had a proximal penetration of 0.08 mm (range 0.00–0.17) and a total penetration of 0.11 mm (range 0.06–0.14). The corresponding values for group 2 were 0,10 mm (0.05–0.21) for proximal penetration and 0.13 mm (0.10–0.16) for total penetration. Between 3 and 6 month the penetration (median values) was 0.04 mm/0.10 mm (proximal/3-D) for group 1 and 0.07 mm/0.12 mm for group 2. With the patients standing we found a proximally migration of the socket (0–6 month) in group 1 of 0,08 mm (−0.07 – 0.21) and 0.12 mm (0.1–0.13) in group 2.

Discussion: Use of a highly cross-linked polyethylene in the socket did not influence the early penetration rate after THR. Early creep of the material is possible explanation.

1-year follow-up on approximately 50% of the patients will be presented at the meeting.


The Journal of Bone & Joint Surgery British Volume
Vol. 81-B, Issue 1 | Pages 135 - 142
1 Jan 1999
Kärrholm J Hultmark P Carlsson L Malchau H

We revised 24 consecutive hips with loosening of the femoral stem using impaction allograft and a cemented stem with an unpolished proximal surface. Repeated radiostereometric examinations for up to two years showed a slow rate of subsidence with a mean of 0.32 mm (−2.0 to +0.31). Fifteen cases followed for a further year showed the same mean subsidence after three years, indicating stabilisation. A tendency to retroversion of the stems was noted between the operation and the last follow-up. Retroversion was also recorded when displacement of the stem was studied in ten of the patients after two years. Repeated determination of bone mineral density showed an initial loss after six months, followed by recovery to the postoperative level at two years. Defects in the cement mantle and malalignment of the stem were often noted on postoperative radiographs, but did not correlate with the degrees of migration or displacement. After one year, increasing frequency of trabecular remodelling or resorption of the graft was observed in the greater trochanter and distal to the tip of the stem. Cortical repair was noted distally and medially (Gruen regions 3, 5 and 6). Migration of the stems was the lowest reported to date, which we attribute to the improved grafting technique and to the hardness of the graft.


The Journal of Bone & Joint Surgery British Volume
Vol. 80-B, Issue 4 | Pages 600 - 606
1 Jul 1998
Garellick G Malchau H Herberts P

We assessed 100 patients with a primary total hip replacement using the Harris hip score and the Nottingham Health Profile at one, three and five years after operation. They were derived from two prospective randomised series of cemented and uncemented replacements.

Both scoring systems correlated highly and were each heavily influenced by the system of functional classification defined by Charnley. After five years both reflected the function of the implant and the general state of the patient. A higher degree of sensitivity is needed to show differences in the performance of an implant in the short and medium term. We do not yet have an ideal system of clinical assessment and the overall function must always be properly assessed.


The Journal of Bone & Joint Surgery British Volume
Vol. 78-B, Issue 6 | Pages 884 - 891
1 Nov 1996
Malchau H Herberts P Wang YX Kärrholm J Romanus B

We enrolled 98 patients (107 hips) with a mean age of 47 years (SD 8.6) into a prospective study of the Madreporic Lord THR; 34 hips had primary and 73 secondary osteoarthritis.

After ten years, the survival rate using revision as the endpoint for failure was 70% (±9) for the cup and 98% (±0.3) for the stem. The combined clinical and radiological survival rates were 46% (±11) and 81% (±10), respectively. Osteoporosis due to stress-shielding was observed in the proximal femur. Hips with radiologically dense bone postoperatively showed the most pronounced bone loss.

We recommend continued radiological follow-up of patients with this type of implant to allow revision to be performed before there is severe bony destruction of the pelvis.