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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. 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 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. 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. 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
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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_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_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. 99-B, Issue SUPP_3 | Pages 53 - 53
1 Feb 2017
Bragdon C Barr C Madanat R Nielsen C Bedair H
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Introduction

A modern total knee replacement system was introduced in 2012 in order to improve the mechanics of total knee replacement (TKR). The purpose of this study was to assess the early clinical and radiographic outcomes of patients who have been treated with this modern TKR system at two years postoperatively.

Methods

Patients who received this TKR system between June of 2012 and September of 2014 were included in this prospective registry-based follow-up study. Demographics, component, and surgical data were collected. Radiographic outcomes were also assessed. Patient reported outcome measures (PROMs) of all patients with 2-year follow-up data were collected. Reasons for revision and overall survival at 2-years were evaluated.


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_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. 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 139 - 139
1 Jul 2014
Ayers D Snyder B Porter A Walcott M Aubin M Drew J Greene M Bragdon C
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Summary Statement

In young, active patients cementless THR demonstrates excellent prosthetic stability by RSA and outstanding clinical outcomes at 5 years using a tapered titanium femoral stem, crosslinked polyethylene liners and either titanium or tantalum shells.

Introduction

Early femoral implant stability is essential to long-term success in total hip replacement. Radiostereometric analysis (RSA) provides precise measurements of micromotion of the stem relative to the femur that are otherwise not detectable by routine radiographs. This study characterised micromotion of a tapered, cementless femoral stem and tantalum porous-coated vs. titanium acetabular shells in combination with highly cross-linked UHMWPE or conventional polyethylene liners using radiostereometric analysis (RSA) for 5 years following THR.


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 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. 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 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.


The Journal of Bone & Joint Surgery British Volume
Vol. 76-B, Issue 1 | Pages 73 - 77
1 Jan 1994
Jasty M Bragdon C Lee K Hanson A Harris W

Fifty-four cobalt-chrome alloy femoral heads were retrieved at revision surgery or at post-mortem; 23 came from uncemented, eight from hybrid and 23 from cemented hip arthroplasties. The uncemented and hybrid implants had porous coating, metal backing and modular femoral heads; with one exception none of the cemented implants had any of these. Twenty-five of the 31 heads from uncemented and hybrid arthroplasties, and 11 of the 23 heads from cemented arthroplasties showed surface damage involving more than 25% of the surface. Scanning electron microscopy revealed multidirectional fine scratches 1 micron to 10 microns in depth and width which appeared to have been made by fine, hard particles. There was a higher rate of such damage in the uncemented and hybrid arthroplasties than in the cemented implants, suggesting that the abrasive particles were mainly released from the metal, rather than from the cement or polyethylene components of the implants.


The Journal of Bone & Joint Surgery British Volume
Vol. 74-B, Issue 4 | Pages 507 - 510
1 Jul 1992
Barrack R Jasty M Bragdon C Haire T Harris W

Six porous-coated, uncemented femoral components were revised at a mean of 34.5 months for persistent thigh pain. At operation the stems were rigidly stable, difficult to extract, and showed good bony ingrowth. The four men and two women, with an average age of 59 years, all had thigh pain starting within the first year, progressive over time and unresponsive to conservative measures. These cases show that rigid fixation with good bony ingrowth does not guarantee the clinical success of a porous-coated uncemented femoral stem.


The Journal of Bone & Joint Surgery British Volume
Vol. 74-B, Issue 1 | Pages 67 - 73
1 Jan 1992
Kwong L Jasty M Mulroy R Maloney W Bragdon C Harris W

The radiographic and histological features of radiolucent areas at the cement-bone interface were correlated in 15 specimens retrieved at post-mortem from patients who had undergone cemented total hip arthroplasty, two weeks to 15 years prior to death. All but one of the components were securely fixed, as demonstrated by direct measurements of micromotion. Extensive radiolucencies were present in all but one case. In 11 of the 14 specimens with radiolucencies, histological examination showed that the radiolucent areas represented regions of osteoporosis and bone remodelling. The remodelling changes were characterised by osteoporosis, cancellisation and thinning of the endosteal cortex, and osteopenia of the trabecular bone. In two specimens the appearance of radiolucency was found to be due to fibrous tissue at the cement-bone interface and in one specimen there was a mixed picture of osteolysis and fibrosis. The study demonstrates that radiolucent lines can occur with well-fixed components and that they may commonly represent osteoporosis rather than the presence of a fibrous membrane at the cement-bone interface.


The Journal of Bone & Joint Surgery British Volume
Vol. 73-B, Issue 4 | Pages 551 - 558
1 Jul 1991
Jasty M Maloney W Bragdon C O'Connor D Haire T Harris W

We studied 16 femora retrieved at post-mortem from symptomless patients who had a satisfactory cemented total hip arthroplasty from two weeks to 17 years earlier, with the aim of delineating the initial mechanisms involved in loosening. Only one specimen showed radiographic evidence of loosening; the other 15 were stable to mechanical testing at 17.0 Nm of torque. In all 16 specimens, the cement-bone interface was intact with little fibrous tissue formation. By contrast, separation at the cement-prosthesis interface and fractures in the cement mantle were frequent. The most common early feature was debonding of the cement from the metal, seen at the proximal and distal ends of the prosthesis. Specimens which had been in place for longer also showed circumferential fractures in the cement, near the cement-metal interface, and radial fractures extending from this interface into the cement and sometimes to the bony interface. The most extensive cement fractures appeared to have started at or near sharp corners in the metal, or where the cement mantle was thin or incomplete. Fractures were also related to voids in the cement. The time relationship in this series suggested that long-term failure of the fixation of cemented femoral components was primarily mechanical, starting with debonding at the interface between the cement and the prosthesis, and continuing as slowly developing fractures in the cement mantle.