Refobacin Bone Cement R and Palacos 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.Aims
Methods
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 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.
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.
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. 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.Aims
Methods
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). 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.Aims
Methods
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. 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.Aims
Methods
This analysis aims to provide an update of the Level-IV Partners Arthroplasty Registry (PAR), a quality-improvement initiative and research data repository. 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.Introduction
Methods
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. 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.Aims
Patients and Methods
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. 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).Aims
Patients and Methods
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. 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).Introduction
Methods
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. 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.Introduction
Methods
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. 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.Introduction
Methods
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.
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.
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.
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.
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 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 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.
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 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 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).Aims
Patients and Methods
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. 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.Aims
Patients and Methods
