What Is the Risk of Revision Surgery in Hydroxyapatite-coated Femoral Hip Stems? Findings From a Large National Registry.

BACKGROUND: Despite wide adoption of hydroxyapatite (HA)-coated femoral stems in THA, no studies have found differences in the risk of revision surgery with its use or investigated the interaction of different prosthesis designs with stem coating. QUESTIONS/PURPOSES: The purpose of this study was to evaluate the risk of revision in THAs with HA-coated stems compared with non-HA-coated. To achieve this purpose, we asked: (1) What is the difference in risk of revision of THAs with HA-coated femoral stems compared with non-HA-coated using an aggregate analysis? (2) What is the difference in risk of revision of THAs with HA-coated femoral stems compared with non-HA-coated for five prosthesis types that used the same femoral and acetabular component combination but where the femoral stem had both a HA and non-HA coating option? METHODS: The Australian Orthopaedic Association National Joint Replacement Registry analyzed cementless primary THA registered between September 1, 1999, and December 31, 2014. Of the 147,645 cases that fit our selection criteria, 81.1% (N = 119,673) had HA-coated stems. Overall (that is, all procedures with any prostheses in the registry) and five prosthesis designs where both an HA-coated stem and non-HA-coated stem exist (Zimmer's VerSys®/Trilogy® [N = 3924], Biomet's Mallory-Head®/Mallory-Head [N = 2538], Smith & Nephew's SL-Plus/EP Fit-Plus [N = 2028], Biomet's Taperloc®/Exceed [N = 1668], and Biomet's Taperloc/Mallory-Head [N = 1240]) were evaluated. Revision surgery was the outcome of interest. Survival analyses were conducted and hazard ratios (HRs) were adjusted for age, sex, bearing surface, femoral head size, and acetabular component HA coating. RESULTS: In the overall cohort, HA stems had a lower any-cause revision risk after 6 months (HR, 0.83; 95% confidence interval [CI], 0.72-0.95; p = 0.007). However, the risk of revision varied when we evaluated the effect of HA on revision for specific prothesis combinations that had both HA and non-HA options for the femoral stem. VerSys/Trilogy, Mallory-Head/Mallory-Head, Taperloc/Exceed, and Taperloc/Mallory-Head did not have a lower risk of any-cause revision with HA-coated stems compared with non-HA-coated. Only the SL-Plus/EP Fit-Plus subgroup showed a lower risk of revision for loosening (HR, 0.17; 95% CI, 0.06-0.44 between 0 and 7 years; p < 0.001) with HA- compared with non-HA-coated stems, but this was observed after an early (< 6 months) higher risk of revision for any reason (HR, 2.88; 95% CI, 1.15-7.21; p = 0.024). CONCLUSIONS: Overall, HA coating of femoral stems was found to be associated with a 17% lower risk of revision for any reason. However, the lower risk of revision associated with HA was not consistent for all prosthesis designs where both HA- and non-HA-coated femoral stem versions were available. Some HA-coated stems have higher revision rates compared with their non-HA-coated versions. Our findings suggest that the effect of HA coating on revision risk varies depending on prosthesis design. LEVEL OF EVIDENCE: Level II, therapeutic study.

Unicompartmental Knee Arthroplasty Revision to TKA: Are Tibial Stems and Augments Associated With Improved Survivorship?

BACKGROUND: Some surgeons contend that unicompartmental knee arthroplasty (UKA) can easily be revised to a TKA when revision is called for, whereas others believe that this can be complex and technically demanding. There has been little research regarding the efficacy or rationale of using metal augmentation and tibial stem extensions when revising a UKA to a TKA. QUESTION/PURPOSES: (1) Is the use of stem extensions for the tibial component associated with increased survival when revising a UKA to a TKA? (2) Is the addition of modular augments associated with increased survival compared with stem extensions alone? (3) Is TKA design (minimally stabilized versus posterior-stabilized) or (4) tibial fixation (cemented versus cementless) associated with differences in survivorship? METHODS: Data from the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) were used to analyze implant survival after revision of a UKA to a TKA, comparing results in which tibial components were used with and without modular components. The groups analyzed were TKA without a stem extension, those in which a tibial stem extension was used, and those in which a tibial stem extension was used together with an augment. There were 4438 revisions of UKAs to TKAs available for analysis. The mean duration of followup of patients having the TKA revisions was 5 years (SD, 3.5 years). There were 2901 (65%) procedures in which a tibial stem extension was not used, 870 (20%) procedures with a tibial stem extension, and 667 (15%) with a tibial stem extension and metallic augment. Kaplan-Meier estimates of survivorship were calculated and hazard ratios (HRs) from Cox proportional hazard models, adjusting for age and sex, were used to compare the rate of revision among groups. The overall 10-year cumulative percent revision (CPR) for UKA revised to a TKA was 16%. RESULTS: At 10 years, the CPR was increased when a stem extension was not used (19%; 95% confidence interval [CI],16.5-20.7 without a stem extension compared with 13%; 95% CI, 9.2-17.0 with a stem extension; entire period HR, 1.44; 95% CI, 1.10-1.89; p = 0.007). There was no difference in the 10-year CPR when an augment was used together with a stem extension compared with a stem extension alone (HR, 1.26; 95% CI, 0.85-1.86; p = 0.251). When minimally stabilized and posterior-stabilized TKAs were compared, there was no difference in survivorship. Minimally stabilized TKA designs without stem extensions showed higher CPR compared with when stem extensions were used (HR, 1.77; 95% CI, 1.16-2.70; p = 0.007), whereas posterior-stabilized designs without stem extensions showed higher CPR only when compared with when stem extensions and augments were both used (HR, 2.16; 95% CI, 1.24-3.77; p = 0.006). Cementless fixation of the tibial component resulted in a higher CPR than when cement was used (HR, 1.36; 95% CI 1.08-1.71; p = 0.008). CONCLUSIONS: In this registry study, the risk of repeat revision after revision of a UKA to a TKA was lower when a tibial stem extension was used, but no such difference was found with respect to augments. Our study did not account for the degree of bone loss or surgeon preference when considering stems and augments. Further research to establish the degree of bone loss associated with UKA to TKA revision procedures will help clarify these findings. LEVEL OF EVIDENCE: Level III, therapeutic study.

Propensity score matching and randomization.

OBJECTIVES: We used elective total joint replacement (TJR) as a case study to demonstrate selection bias toward offering this procedure to younger and healthier patients. STUDY DESIGN AND SETTING: Longitudinal data from 2,202 men were integrated with hospital data and mortality records. Study participants were followed from recruitment (1996-1999) until TJR, death, or 2007 (end of follow-up). A propensity score (PS) was constructed to quantify each subject's likelihood of undergoing TJR. TJR recipients were later matched to their non-TJR counterparts by PS and year of hospitalization. Ten-year mortality from index admission was compared between cases and controls. RESULTS: Overall, 819 (37.2%) had TJR. Those were younger, healthier, and belonged to higher socioeconomic classes compared with those who were not proposed for surgery. Of the TJR recipients, 718 were matched to 1,109 controls. Cases and controls had similar characteristics and similar years of follow-up from recruitment till index admission. Nonetheless, controls were more likely to die (39.5%) compared with 14.5% in TJR cases (P < 0.001). CONCLUSION: Selection for elective procedures may introduce bias in prognostic features not accounted for by PS matching. Caution must be exercised when long-term outcomes are compared between surgical and nonsurgical groups in a population at risk for that surgical procedure.

Smoking and primary total hip or knee replacement due to osteoarthritis in 54,288 elderly men and women.

BACKGROUND: The reported association of smoking with risk of undergoing a total joint replacement (TJR) due to osteoarthritis (OA) is not consistent. We evaluated the independent association between smoking and primary TJR in a large cohort. METHODS: The electronic records of 54,288 men and women, who were initially recruited for the Second Australian National Blood Pressure study, were linked to the Australian Orthopaedic Association National Joint Replacement Registry to detect total hip replacement (THR) or total knee replacement (TKR) due to osteoarthritis. Competing risk regressions that accounted for the competing risk of death estimated the subhazard ratios for TJR. One-way and probabilistic sensitivity analyses were undertaken to represent uncertainty in the classification of smoking exposure and socioeconomic disadvantage scores. RESULTS: An independent inverse association was found between smoking and risk of THR and TKR observed in both men and women. Compared to non-smokers, male and female smokers were respectively 40% and 30% less likely to undergo a TJR. This significant association persisted after controlling for age, co-morbidities, body mass index (BMI), physical exercise, and socioeconomic disadvantage. The overweight and obese were significantly more likely to undergo TJR compared to those with normal weight. A dose-response relationship between BMI and TJR was observed (P < 0.001). Socioeconomic status was not independently associated with risk of either THR or TKR. CONCLUSION: The strengths of the inverse association between smoking and TJR, the temporal relationship of the association, together with the consistency in the findings warrant further investigation about the role of smoking in the pathogenesis of osteoarthritis causing TJR.

Joint registry approach for identification of outlier prostheses.

BACKGROUND AND PURPOSE: Joint Replacement Registries play a significant role in monitoring arthroplasty outcomes by publishing data on survivorship of individual prostheses or combinations of prostheses. The difference in outcomes can be device- or non-device-related, and these factors can be analyzed separately. Although registry data indicate that most prostheses have similar outcomes, some have a higher than anticipated rate of revision when compared to all other prostheses in their class. This report outlines how the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) has developed a method to report prostheses with a higher than expected rate of revision. These are referred to as "outlier" prostheses. MATERIAL AND METHODS: Since 2004, the AOANJRR has developed a standardized process for identifying outliers. This is based on a 3-stage process consisting of an automated algorithm, an extensive analysis of individual prostheses or combinations by registry staff, and finally a meeting involving a panel from the Australian Orthopaedic Association Arthroplasty Society. Outlier prostheses are listed in the Annual Report as (1) identified but no longer used in Australia, (2) those that have been re-identified and that are still used, and (3) those that are being identified for the first time. RESULTS: 78 prostheses or prosthesis combinations have been identified as being outliers using this approach (AOANJRR 2011 Annual Report). In addition, 5 conventional hip prostheses were initially identified, but after further analysis no longer met the defined criteria. 1 resurfacing hip prosthesis was initially identified, subsequently removed from the list, and then re-identified the following year when further data were available. All unicompartmental and primary total knee prostheses identified as having a higher than expected rate of revision have continued to be re-identified. INTERPRETATION: It is important that registries use a transparent and accountable process to identify an outlier prosthesis. This paper describes the development, implementation, assessment, and impact of the approach used by the Australian Registry.

Total joint replacement in men: old age, obesity and in-hospital complications.

BACKGROUND: We assessed risks of incident in-hospital complications and 1-year and 5-year mortality following elective primary total joint replacement (TJR), focusing on obesity. METHODS: Longitudinal data from a population-based cohort of 819 men who had had TJR were integrated with validated hospital morbidity data and mortality records. Complications recorded in the index admission were classified as major or minor by 13 independent orthopaedic surgeons. RESULTS: Of 819 men (mean age 76.3 (SD 4.5) years), 331 patients (40.4%) had an in-hospital complication from whom 155 (18.9%) had at least one major complication that was classified as potentially life threatening. Obesity and age were independently associated with increased risk of major complications. Compared with patients without complications, those with major complications experienced significantly greater mortality in 1 year (5.8% versus 1.2%, P = 0.001) and 5 years (16.8% versus 8.0%, P = 0.002) following TJR. In Cox regressions, age, Charlson Co-morbidity index and major complications were independently associated with 1-year mortality. Age and Charlson Co-morbidity index were also associated with 5-year mortality. Similarly, risk of dying within 5 years of TJR was higher among patients with class II obesity compared with patients with normal weight. The most frequently reported complications were those in the cardio-respiratory and general systems. Complications in the cardio-respiratory system significantly increased hazard of 1- and 5-year mortality. CONCLUSION: The elderly and the obese are more likely to develop adverse outcomes following a primary TJR. Our findings may assist clinicians in better selecting elderly patients for surgery, and informing them about their individual level of risk.

Use of routine hospital morbidity data together with weight and height of patients to predict in-hospital complications following total joint replacement.

BACKGROUND: Routinely collected data such as hospital morbidity data (HMD) are increasingly used in studying clinical outcomes among patients undergoing total joint replacement (TJR). These data are readily available and cover large populations. However, since these data were not originally collected for the purpose of health research, a rigorous assessment of their quality is required. We assessed the accuracy of the diagnosis of obesity in HMD and evaluated whether the augmentation of HMD with actual weight and height of patients could improve their ability to predict major in-hospital complications following total joint replacement in men. METHODS: The electronic records of 857 participants in the Health In Men Study (HIMS) who had had TJR were linked with Western Australia HMD. HMD-recorded diagnosis of obesity was validated using the actual weight and height obtained from HIMS. In-hospital major complications were modelled using multivariable logistic regressions that either included the actual weight and height or HMD-recorded obesity. Model discrimination was calculated using area under ROC curve. RESULTS: The HMD failed to detect 70% of the obese patients. Only 64 patients (7.5%) were recorded in HMD as obese although 216 (25%) were obese [BMI: ≥30kg/m2] (sensitivity: 0.2, positive predictive value: 0.7). Overall, 174 patients (20%) developed an in-hospital major complication which was significantly higher in the overweight and obese comparing with patients with normal weight. HMD-recorded obesity was not independently associated with major complications, whereas a dose-response relationship between weight and these complications was observed (P=0.004). Using the actual weight and height of the participants instead of HMD-recorded diagnosis of obesity improved model discrimination by 9%, with areas under ROC curve of: 0.69, 95% CI: 0.64-0.73 for the model with HMD-recorded obesity compared with 0.75, 95% CI: 0.70-0.79 for the model with actual weight and height, P<0.001. CONCLUSION: Body weight is an important risk factor for in-hospital complications in patients undergoing TJR. HMD systems do not include weight and height as variables whose recording is mandatory. Augmenting HMD with patients' weight and height may improve prediction of major complications following TJR. Our study suggests making these variables mandatory in any hospital morbidity data system.

Smoking, body weight, physical exercise, and risk of lower limb total joint replacement in a population-based cohort of men.

OBJECTIVE: To assess the associations of smoking, body weight, and physical activity with risk of undergoing total joint replacement (TJR) in a population-based cohort of men. METHODS: A cohort study of 11,388 men that integrated clinical data with hospital morbidity data and mortality records was undertaken. The risk of undergoing TJR was modeled on baseline weight, height, comorbidity, socioeconomic status, years of smoking, and exercise in 3 separate age groups, using Cox proportional hazards regressions and competing risk regressions (CRRs). RESULTS: Dose-response relationships between weight and risk of TJR and between smoking and risk of TJR were observed. Being overweight independently increased the risk of TJR, while smoking lowered the risk. The decreased risk among smokers was demonstrated in both Cox and CRR models and became apparent after 23 years of exposure. Men who were in the highest quartile (≥48 years of smoking) were 42-51% less likely to undergo TJR than men who had never smoked. Tests for trend in the log hazard ratios (HRs) across both smoking and weight quantiles yielded significant P values. Vigorous exercise increased the hazard of TJR; however, the association reached statistical significance only in the 70-74-year-old age group (adjusted HR 1.64 [95% confidence interval 1.19-2.24]). Adjusting for Deyo-Charlson Index or Elixhauser's comorbidity measures did not eliminate these associations. CONCLUSION: Our findings indicate that being overweight and reporting vigorous physical activity increase the risk of TJR. This study is the first to demonstrate a strong inverse dose-response relationship between duration of smoking and risk of TJR. More research is needed to better understand the role of smoking in the pathogenesis of osteoarthritis.

Five-year results of the ASR XL Acetabular System and the ASR Hip Resurfacing System: an analysis from the Australian Orthopaedic Association National Joint Replacement Registry.

BACKGROUND: Articular Surface Replacement (ASR) hip prostheses, which have metal-on-metal bearing surfaces, were manufactured by DePuy Orthopaedics (Warsaw, Indiana) for use in both conventional total hip arthroplasty and hip resurfacing. Both the ASR XL Acetabular System and the ASR Hip Resurfacing System were recently recalled worldwide by the manufacturer. This report summarizes an analysis by the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) of the outcome of arthroplasties involving the ASR prostheses. METHODS: The first recorded use of the ASR XL Acetabular System in Australia occurred in 2004, and the Registry recorded 4406 procedures involving this system through December 31, 2009. The first recorded use of the ASR Hip Resurfacing System in Australia occurred in 2003, and the Registry recorded 1167 procedures through December 31, 2009. The Kaplan-Meier method and proportional-hazard modeling were used to compare the revision rate of primary total hip arthroplasties involving the ASR XL Acetabular System with that of arthroplasties involving all other conventional prostheses as well as with that of arthroplasties involving all other conventional prostheses with a metal-on-metal-articulation. In addition, the revision rate of primary arthroplasties involving the ASR Hip Resurfacing System was compared with that of arthroplasties involving all other hip resurfacing prostheses. Patient demographics, prosthesis characteristics, and information regarding the type of revision and the reason for revision were also compared. RESULTS: Arthroplasties involving both ASR designs had a significantly greater revision rate compared with those involving all other prostheses. The cumulative revision rate of arthroplasties involving the ASR XL Acetabular System at five years postoperatively was 9.3% (95% confidence interval [CI], 7.3% to 11.9%) compared with 3.4% (95% CI, 3.3% to 3.5%) for total hip arthroplasties involving all other conventional prostheses. The cumulative revision rate of arthroplasties involving the ASR Hip Resurfacing System at five years postoperatively was 10.9% (95% CI, 8.7% to 13.6%) compared with 4.0% (95% CI, 3.7% to 4.5%) for arthroplasties involving all other resurfacing prostheses. Arthroplasties involving the ASR XL Acetabular System had a greater rate of revision due to implant loosening and/or osteolysis and due to metal sensitivity compared with total hip arthroplasties involving all other conventional prostheses. Arthroplasties involving the ASR XL Acetabular System also had a significantly greater revision rate compared with total hip arthroplasties involving all other conventional metal-on-metal prostheses. Arthroplasties involving the ASR Hip Resurfacing System had a greater rate of revision due to metal sensitivity compared with total hip arthroplasties involving all other resurfacing prostheses. CONCLUSIONS: ASR prostheses used in conventional hip arthroplasty and in hip resurfacing exhibited a greater revision rate compared with other prostheses in the AOANJRR. These results are consistent with those derived from other registries and from published studies of individual cohorts.

What is the benefit of introducing new hip and knee prostheses?

BACKGROUND: New joint replacement prostheses are being continually introduced into the market. The underlying purpose of the introduction of new devices is to improve patient outcomes. This study was undertaken to determine how many new prostheses were associated with improved patient outcomes. BACKGROUND: Data were obtained from a comprehensive national database. Outcome analysis was performed on all new hip and knee prostheses introduced into the market between January 1, 2003, and December 31, 2007, and used on at least 100 occasions. The findings were compared with the combined results of the three best performing established hip and knee prostheses with a minimum duration of follow-up of five years. The principal outcome measures were the rate of revision per observed component years and the time to first revision, with use of Kaplan-Meier estimates of implant survivorship. RESULTS: Most prostheses introduced into the market during the study period were used on fewer than 100 occasions. Analysis of those that had been used in a sufficient number of procedures showed that 27% (nine of thirty-three) of the hip replacements and 29% (eight of twenty-eight) of the knee replacements had a significantly higher rate of revision than the established prostheses. None of the newer prostheses had a lower rate of revision than the established prostheses. CONCLUSION: This study indicates that there was no benefit to the introduction of new prostheses into this national market during the five-year study period. Importantly, 30% of the new prostheses were associated with a significantly worse outcome compared with the prostheses with a minimal duration of follow-up of five years.

Poor outcome of revised resurfacing hip arthroplasty.

BACKGROUND AND PURPOSE: Recent years have seen a rapid increase in the use of resurfacing hip arthroplasty despite the lack of literature on the long-term outcome. In particular, there is little evidence regarding the outcome of revisions of primary resurfacing. The purpose of this analysis was to examine the survivorship of primary resurfacing hip arthroplasties that have been revised. PATIENTS AND METHODS: Over 12,000 primary resurfacing hip arthroplasties were recorded by the Australian Orthopaedic Association National Joint Replacement Registry between September 1, 1999 and December 31, 2008. During this time, 397 revisions for reasons other than infection were reported for these primary resurfacings and classified as acetabular, femoral, or both acetabular and femoral revisions. The survivorship of the different types of revisions was estimated using the Kaplan-Meier method and compared using proportional hazard models. Additionally, the outcome of a femoral-only revision was compared to that of primary conventional total hip arthroplasty. RESULTS: Acetabular-only revision had a high risk of re-revision compared to femoral-only and both acetabular and femoral revision (5-year cumulative per cent revision of 20%, 7%, and 5% respectively). Femoral-only revision had a risk of re-revision similar to that of revision of both the acetabular and femoral components. Femoral-only revision had over twice the risk of revision of primary conventional total hip arthroplasty. INTERPRETATION: Revision of a primary resurfacing arthroplasty is associated with a major risk of re-revision. The best outcome is achieved when either the femoral-only or both the acetabular and femoral components are revised. Technically straightforward femoral-only revisions generally have a worse outcome than a primary conventional total hip arthroplasty.

Outcome of revision of unicompartmental knee replacement.

BACKGROUND AND PURPOSE: Despite concerns regarding a higher risk of revision, unicompartmental knee arthroplasty (UKA) continues to be used as an alternative to total knee arthroplasty (TKA). There are, however, limited data on the subsequent outcome when a UKA is revised. We examined the survivorship for primary UKA procedures that have been revised. METHODS: We used data from the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) to analyze the survivorship of 1,948 revisions of primary UKA reported to the Registry between September 1999 and December 2008. This was compared to the results of revisions of primary TKA reported during the same period where both the femoral and tibial components were revised. The Kaplan-Meier method for modeling survivorship was used. RESULTS: When a primary UKA was revised to another UKA (both major and minor revisions), it had a cumulative per cent revision (CPR) of 28 and 30 at 3 years, respectively. The CPR at 3 years when a UKA was converted to a TKA was 10. This is similar to the 3-year CPR (12) found earlier for primary TKA where both the femoral and tibial components were revised. INTERPRETATION: When a UKA requires revision, the best outcome is achieved when it is converted to a TKA. This procedure does, however, have a major risk of re-revision, which is similar to the risk of re-revision of a primary TKA that has had both the femoral and tibial components revised.