Porous Tantalum Metaphyseal Cones for Severe Femoral and Tibial Bone Defects in Revision Total Knee Arthroplasty are Reliable for Fixation at Mean 5-Year Follow-Up.

BACKGROUND: Porous tantalum metaphyseal cones may facilitate reconstructions of severe bone defects during revision total knee arthroplasty (TKA), but there remains a paucity of data on their outcomes at mean 5 years of follow-up. This study reports the component survivorship, patient satisfaction, functional outcomes, radiographic osseointegration, and complications of revision TKA with porous tantalum metaphyseal cones at mid-term (mean 5-year) follow-up. METHODS: This study included 152 patients who had a mean age of 66 years (range, 33 to 86 years) undergoing revision TKA with porous tantalum metaphyseal cones. Indications for surgery included aseptic loosening (n = 87, 57.3%), second-stage reimplantation for infection (n = 42, 27.6%), osteolysis with well-fixed components (n = 20, 13.2%), and periprosthetic fracture (n = 3, 2.0%). Component survivorship, clinical outcomes, radiographic outcomes, and any complications were recorded. The mean follow-up time was 5.6 years (range, 2.2 to 13.7). RESULTS: Survivorship was 100% when the end point was revision of the metaphyseal cone (no cones were revised) and 83.8% (95% confidence interval: 77.9 to 90.2%) when the end point was reoperation for any reason at 5-year follow-up. Reoperations were performed for infection (n = 10), instability (n = 4), periprosthetic fracture (n = 2), and quadriceps rupture/dehiscence (n = 3). The mean patient satisfaction score was 78.8 ± 11.3 and the mean Forgotten Joint Score was 62.2 ± 16.7 at the final follow-up. The preoperative median University of California at Los Angeles score improved from 2 (interquartile range 2 to 3) to 6 points (interquartile range 5 to 6) (P < .001), and the preoperative Oxford knee score improved from 15.2 ± 3.8 to 39.4 ± 5.1 points (P < .001) at the final follow-up. All metaphyseal cones showed radiographic evidence of osteointegration without any subsidence or loosening. CONCLUSIONS: Porous tantalum metaphyseal cones enabled robust reconstructions of severe femoral and tibial bone defects during revision TKA. These reconstructions were associated with excellent survivorship, improvements in functional outcomes, and reproducible radiographic osseointegration at mean 5-year follow-up. The most common reasons for reoperation were infection and instability.

Clinical Outcomes and Risk Factors for Re-Revision Due to Trunnion Corrosion in Primary Metal-on-Polyethylene Total Hip Arthroplasty.

BACKGROUND: There is a paucity of literature regarding the mid-term (greater than 2 years) outcomes of revision for adverse local tissue reaction to metal debris due to corrosion at the head-neck junction (trunnionosis) in metal-on-polyethylene total hip arthroplasty (THA), and risk factors for re-revision remain largely unknown. We aimed to report the re-revision-free survival and functional outcomes for this patient population and to identify risk factors for re-revision. METHODS: A total of 80 hips (79 patients) with a metal-on-polyethylene THA who had undergone revision for trunnionosis at our institution were included. The mean study follow-up from index trunnionosis revision was 4.6 years (range, 2.0 to 9.4). Kaplan-Meier survival analysis was performed with all-cause re-revision as the end point, and multivariate logistic regression was used to identify risk factors for re-revision. RESULTS: We saw that twenty-one hips (26%) underwent re-revision at a mean of 8.0 months (range, 0.03 to 36.3) after the index trunnionosis revision, most commonly for instability and infection. The two- and five-year all-cause re-revision-free survival rates were 75.0 and 73.2%, respectively. The mean Oxford Hip Score was 33.7 (range, 11 to 48); 76% were satisfied, and 24% were dissatisfied with their hip. Multivariate analysis identified not undergoing a cup revision (odds ratio: 4.5; 95% confidence interval: 1.03 to 19.7) and time from primary THA to the index trunnionosis revision (odds ratio: 0.77; 95% confidence interval: 0.62 to 0.97) as risk factors for undergoing re-revision. CONCLUSIONS: The risk of early re-revision for these patients is high (26%), mostly due to infection and instability, and functional outcomes are fair. Not performing a cup revision appears to be a risk factor for re-revision, as is the shorter time from primary THA to trunnionosis revision. LEVEL OF EVIDENCE: III.

The John Charnley Award: The Impact of Human Leukocyte Antigen Genotype on Bacterial Infection Rates and Successful Eradication in Total Hip Arthroplasty.

BACKGROUND: Genetics play an important role in several medical domains; however, the influence of human leukocyte antigen (HLA) genotype on the development of periprosthetic joint infection (PJI) in total hip arthroplasty (THA) remains unknown. The primary aim of this study was to determine if HLA genotype is associated with the development of bacterial PJI in THA. Secondarily, we evaluated the association between HLA genotype and PJI treatment success. METHODS: A retrospective, matched, case-control study was performed using prospectively collected data from a single institution. A total of 49 patients who underwent primary THA were included, with a mean follow-up of 8.5 years (range, 4.2 to 12.9). The 23 cases (PJI) and 26 controls (no PJI) were matched for age, sex, follow-up, body mass index, primary diagnosis, and comorbidities (P > .05). High-resolution genetic analysis targeting 11 separate HLA loci was performed in all patients using serum samples. The HLA gene frequencies and carriage rates were determined and compared between cohorts. A subgroup analysis of PJI treatment success (18) and failure (5) was performed. Statistical significance was set at P = .10 for genetic analysis and at 0.05 for all other analyses. RESULTS: There were 4 HLA alleles that were significantly associated with the development of PJI. The 3 at-risk alleles included HLA-C∗06:02 (odds ratio 5.25, 95% CI [confidence interval] 0.96 to 28.6, P = .064), HLA-DQA1∗04:01 (P = .096), and HLA-DQB1∗04:02 (P = .096). The single protective allele was HLA-C∗03:04 (odds ratio 0.12, 95% CI 0.01 to 1.10, P = .052). There were no specific HLA alleles that were associated with treatment success or failure. CONCLUSIONS: This study suggests that there are at-risk and protective HLA alleles associated with the development of PJI in THA. To our knowledge, this is the first study to demonstrate an association between patient HLA genotype and the development of PJI. A larger study of the subject matter is necessary and warranted.

The Diagnostic Utility of Serum Metal Ion Markers for High-Grade Aseptic Lymphocyte-Dominated Vasculitis-Associated Lesions (ALVALs) in Revision Hip and Knee Arthroplasty: An International Multicenter Study.

BACKGROUND: Aseptic lymphocyte-dominated vasculitis-associated lesions (ALVALs) are typically described in the context of metal-on-metal (MoM) hip bearings. This study explores the diagnostic utility of preoperative serum cobalt and chromium ion levels in determining the histological grade of ALVAL in revision hip and knee arthroplasty. METHODS: This was a multicenter retrospective review of 26 hips and 13 knees assessing the correlation between preoperative ion levels (mg/L (ppb)) and the histological grade of ALVAL from intraoperative specimens. The diagnostic ability of preoperative serum cobalt and chromium levels to determine high-grade ALVAL was assessed using a receiver operating characteristic (ROC) curve. RESULTS: In the knee cohort, there was a higher serum cobalt level in high-grade ALVAL cases (10.2 mg/L (ppb) versus 3.1 mg/L (ppb)) (P = .0002). The Area Under the Curve (AUC) was 1.00 (95% confidence interval (CI) 1.00 to 1.00). There was a higher serum chromium level in high-grade ALVAL cases (12.25 mg/L (ppb) versus 7.77 mg/L (ppb)) (P = .0002). The AUC was 0.806 (95% CI 0.555 to 1.00). In the hip cohort, there was a higher serum cobalt level in high-grade ALVAL cases (333.5 mg/L (ppb) versus 119.9 mg/L (ppb)) (P = .0831). The AUC was 0.619 (95% CI 0.388 to 0.849). There was a higher serum chromium level in high-grade ALVAL cases (186.4 mg/L (ppb) versus 79.3 mg/L (ppb)) (P = .183). The AUC was 0.595 (95% CI 0.365 to 0.824). CONCLUSIONS: Histologically, high-grade ALVAL has significantly higher preoperative serum cobalt and chromium ion levels in revision TKA. Preoperative serum ion levels have excellent diagnostic utility in revision TKA. Cobalt levels in revision THA have a fair diagnostic ability and chromium levels had a poor diagnostic ability.

Risk factors for failure of manipulation under anesthesia after total knee arthroplasty.

BACKGROUND: Manipulation under anesthesia (MUA) is a well-established treatment for stiffness after total knee arthroplasty (TKA). Risk factors for failure of MUA remain largely unknown. The primary aim of this study was to identify risk factors for failure of MUA after TKA. METHODS: We performed a retrospective cohort study including 470 patients who underwent MUA after primary TKA with minimum 2 year follow-up. Patients were grouped into success (n = 412) or failure (n = 58) cohorts; failure was defined as flexion < 90° at most recent follow-up or revision for stiffness. The increase in flexion post-MUA for the cohort was calculated. Several clinical, patient, and surgical factors were analyzed using univariate, followed by multivariable logistic regression models to identify independent risk factors associated with failure. RESULTS: The mean increase in flexion was 42° (range 0-115). BMI 30-35 (p = 0.01, odds ratio (OR) 2.42; 95% CI 1.25-4.68) and poorer pre-MUA flexion (p < 0.01, OR 1.43; 95% CI 1.23-1.67) were risk factors for failure. When considering revision for stiffness only, BMI 30-35 (p = 0.01, OR 3.27; 95% CI 1.41-7.61), lower pre-MUA flexion (p < 0.01, OR 1.43; 95% CI 1.18-1.75), and history of prior knee surgery (p = 0.04, OR 2.31; 95% CI 1.06-5.04) were predictors of failure. Time to MUA (p = 0.48), thromboprophylaxis (p = 0.44), pre-operative opioid use (p = 0.34), depression/anxiety (p = 1.0), and several other factors analyzed were not associated with failure. CONCLUSION: In this large cohort, elevated BMI and lower pre-MUA flexion were risk factors for failure of MUA. History of prior knee surgery was an additional predictor of requiring revision for stiffness.

Can Technology Assistance be Cost Effective in TKA? A Simulation-Based Analysis of a Risk-prioritized, Practice-specific Framework.

BACKGROUND: Robotic, navigated, and patient-specific instrumentation (PSI) TKA procedures have been introduced to improve component placement precision and improve implant survivorship and other clinical outcomes. However, the best available evidence has shown that these technologies are ineffective in reducing revision rates in the general TKA patient population. Nonetheless, it seems plausible that these technologies could be an effective and cost-effective means of reducing revision risk in clinical populations that are at an elevated risk of revision because of patient-specific demographics (such as older age at index surgery, elevated BMI, and being a man). Since clinical trials on this topic would need to be very large, a simulation approach could provide insight on which clinical populations would be the most promising for analysis. QUESTIONS/PURPOSES: We conducted a simulation-based analysis and asked: (1) Given key demographic parameters characterizing a patient population, together with estimates of the precision achievable with selected forms of technology assistance in TKA, can we estimate the expected distributions of anticipated reductions in lifetime revision risk for that population and the associated improvements in quality-adjusted life years (QALYs) that would be expected to result? (2) Are there realistic practice characteristics (such as combinations of local patient demographics and capital and per-procedure costs) for which applying a per-patient risk-prioritized policy for using technology-assisted TKA could be considered cost-effective based on projected cost savings from reductions in revision rates? METHODS: We designed simulations of hypothetical practice-specific clinical scenarios, each characterized by patient volume, patient demographics, and technology-assisted surgical technique, using demographic information drawn from other studies to characterize two contrasting simulated clinical scenarios in which the distributions of factors describing patients undergoing TKA place one population at a comparatively elevated risk of revision (elevated-risk population) and the second at a comparatively reduced risk of revision (lower-risk population). We used results from previous systematic reviews and meta-analyses to estimate the implant precision in coronal plane alignment for patient-specific instrumentation, navigated, and robotic technology. We generated simulated TKA patient populations based on risk estimates from large clinical studies, structured reviews, and meta-analyses and calculated the patient-specific reduction in the revision risk and the change in QALYs attributable to the technology-assisted intervention in each of the two simulated clinical scenarios. We also incorporated a sensitivity analysis, incorporating variations in the effect size of deviations from overall coronal alignment on revision risk and difference in health state utilities acquired through a structured review process. We then simulated the outcomes of 25,000 operations per patient using the precisions associated with the conventional TKA technique, the three technology-assisted techniques, and a hypothetical technology-assisted intervention that could consistently deliver perfectly neutral overall coronal alignment, which is unachievable in practice. A risk-prioritized treatment policy was emulated by ordering the simulated patients from the highest to lowest predicted increase in QALYs, such that simulated patients who would see the greatest increase in the QALYs (and therefore the greatest reduction in lifetime revision risk) were the patients to receive technology-assisted TKA intervention in a practice. We used cost estimates acquired through a structured review process and calculated the net added costs of each of the three technology-assisted techniques as a function of the percent utilization (proportion of patients treated with technology assistance in a practice), factoring in fixed costs, per-procedure variable costs, and savings occurring from the prevention of future revision surgery. Finally, we calculated the incremental cost-effectiveness ratio (ICER) and marginal cost-effectiveness ratio (MCER) for each technology-assisted technique for the two clinical scenarios. We then used a Monte Carlo approach to simulate variations in key patient risk, health state, and economic factors as well as to obtain a distribution of estimates for cost-effectiveness. We considered an intervention to be cost effective if either the ICER or MCER values were below USD/QALY 63,000. RESULTS: For the lower-risk population, the median reduction in the revision risk was 0.9% (0.4% to 2.2%, extrema from the sensitivity analysis) and 1.8% (0.9% to 4.4%) for PSI and robotic TKA, respectively, and 1.9% (1.0% to 4.6%) for ideal TKA. In contrast, the median reduction in the revision risk in the elevated-risk clinical scenario was 2.0% (1.2% to 3.4%) and 4.6% (2.7% to 8.5%) for PSI and robotic TKA and 5.1% (3.0% to 9.4%) for ideal TKA. Estimated differences in the cumulative gain in QALYs attributable to technology-assisted TKA ranged from 0.6 (0.2 to 1.8) to 4.0 (1.8 to 10.0) QALYs per 100 patients, depending on the intervention type and clinical scenario. For PSI, we found treating 15% of patients in the lower-risk population and 77% in the elevated-risk population could meet the threshold for being considered cost effective. For navigated TKA systems offering high alignment precision, we found the intervention could meet this threshold for practice sizes of at least 300 patients per year and a percent utilization of 27% in the lower-risk population. In the elevated-risk population, cost-effectiveness could be achieved in practice volumes as small as 100 patients per year with a percent utilization of at least 6%, and cost savings could be achieved with a percent utilization of at least 45%. We found that robotic TKA could only meet the threshold for being considered cost-effectiveness in the lower-risk population if yearly patient volumes exceeded 600 and for a limited range of percent utilization (27% to 32%). However, in the elevated-risk patient population, robotic TKA with high alignment precision could potentially be cost effective for practice sizes as small as 100 patients per year and a percent utilization of at least 20% if a risk-prioritized treatment protocol were used. CONCLUSION: Based on these simulations, a selective-use policy for technology-assisted TKA that prioritizes using technology assistance for those patients at a higher risk of revision based on patient-specific factors could potentially meet the cost-effectiveness threshold in selected circumstances (for example, primarily in elevated-risk populations and larger practice sizes). Whether it does meet that threshold would depend significantly on the surgical precision that can be achieved in practice for a given proposed technology as well as on the true local costs of using the proposed technology. We further recommend that any future randomized trials seeking to demonstrate possible effects of technology assistance on revision risk focus on clinical populations that are at higher risk of revision (such as, patient populations that are relatively younger, have higher BMIs, and higher proportions of men). CLINICAL RELEVANCE: This study suggests that technology assistance is only likely to prove cost effective in selected circumstances rather than in all clinical populations and practice settings. In general, we project that surgical navigation is most likely to prove cost effective in the widest range of circumstances, that PSI may be cost effective or cost neutral in a moderate range of circumstances, and that robotic surgery is only likely to be cost effective in moderately large practices containing patients who are on average at an intrinsically elevated risk of revision.

Comparison of Clinical and Functional Outcomes in One versus Two Component Revision for Total Knee Arthroplasty.

BACKGROUND: Revisions of total knee arthroplasties (TKAs) may require revision of one or both tibial and femoral components. Our purpose was to examine the clinical and functional outcomes in 1- versus 2-component TKA revisions. METHODS: We identified 92 1-component (tibial or femoral) revisions at a single center. Our inclusion criteria were isolated revision of the tibial or femoral components with a minimum 2-year follow-up. The included cases were matched 1:2 with a control group of 2-component revisions (tibial and femoral) by age, body mass index, American Society of Anesthesiologists score, and indication for revision. We collected demographics, complications, operative times, any subsequent rerevisions, and functional outcome scores. RESULTS: The median follow-up time for the 1- and 2-component revision groups were 10 years (range, 3 to 17) and 8 years (range, 2 to 18), respectively. The most common complication after rerevision in both groups was stiffness at 9 of 92 (9.8%) and 9 of 170 (5.3%) in the 1- and 2-component groups, respectively (P = .20). The overall complication prevalence in the 1- and 2- component revision groups was similar 20 of 92 (22%) and 35 of 170 (21%), respectively (P = .87). Subsequent rerevisions for any indication were encountered in 12 of 92 (13.0%) of the 1-component and 18 of 170 (11%) in the 2-component groups (P = .69). There was no statistical difference in survivorship or functional outcomes scores between the groups. CONCLUSION: Our results showed that isolated revision of a single TKA component is an acceptable option, with comparable functional outcomes, complications, and survivorships when compared with both-component revision. As such, a 1-component revision should be considered where appropriate.

The Desired Oxford Knee Score Obtained Before Total Knee Arthroplasty is Predictive of the Postoperative Oxford Knee Score: A Prospective Study.

BACKGROUND: The relationship between patient expectations and patient-reported outcome measures (PROMs) after total knee arthroplasty (TKA) is not well understood. The purpose of the study was to test the influence of desired knee function on postoperative perceived knee function 1 year after TKA. METHODS: A total of 102 patients undergoing primary TKA were available for data analyses. Preoperatively, patients completed the Oxford Knee Score (OKS) twice, one representing preoperative function (preoperative OKS); the second representing desired function after TKA (desired OKS). Western Ontario and McMaster Universities Arthritis Index (WOMAC), University of California, Los Angeles (UCLA) Activity score, Hospital for Special Surgery Knee Replacement Expectations Survey (HSS-KRES), Patient Health Questionnaire-9, and EuroQol-visual analogue scales were obtained preoperatively. One year after surgery, all surveys besides the UCLA activity score and HSS-KRES were repeated. The associations between postoperative OKS and WOMAC versus desired OKS and HSS-KRES were assessed using multivariable linear regression models, wherein linear regression coefficients represent the additive effect on the mean postoperative PROM. RESULTS: The desired OKS was independently associated with the postoperative OKS (linear regression coefficient = 0.43; P = .011), that is, each point increase in desired OKS yielded a 0.43 increase in postoperative OKS. The preoperative OKS showed no association with postoperative PROMs. Desired OKS was correlated with postoperative WOMAC (coefficient = -0.67; P = .014). The HSS-KRES was not associated with the postoperative OKS (coefficient = -0.005; P = .965) or WOMAC (coefficient = 0.18; P = .288). CONCLUSION: In TKA patients, higher preoperative desired function predict greater postoperative PROMs. Effects of preoperative expectations on outcomes are independent of patient demographics or preoperative function.

Quality indicators in primary elective total hip and knee arthroplasty.

PURPOSE: Total hip arthroplasty (THA) and total knee arthroplasty (TKA) represent a significant portion of healthcare spending and are high-priority for quality improvement initiatives. This study aims to develop quality indicators (QIs) in the care of primary elective THA and TKA patients. These QIs serve a number of purposes including documentation of the quality of care, objective comparisons of institutions/providers, facilitating pay-for-performance initiatives, and supporting accountability, regulation, and accreditation. METHODS: A guideline-based approach, initially described by Kötter et al., was utilized. Eight clinical practice guidelines (CPGs) were evaluated for candidate indicators (CIs). CIs with high-quality evidence and consensus statements were extracted. Eighteen additional CIs were included from previous work that evaluated quality improvement databases. Each CI and supporting evidence was submitted for independent review by an expert panel. The RAND Corporation-University of California, Los Angeles (RAND/UCLA) appropriateness methodology was utilized and items were rated based on validity, reliability, and feasibility of measurement. After two rounds of ratings and ranking, a final ranked list of QIs was obtained. RESULTS: Fifty-six CIs were identified from the literature and CPGs or proposed by the expert panel. Two rounds of voting resulted in 12 total QIs that were deemed appropriate measures of high-quality care. The final 12 QIs were ranked by order of importance: use of peri-operative tranexamic acid, infusion of prophylactic antibiotics prior to inflation of tourniquet, appropriate post-operative venous thromboembolic prophylaxis, complication rate, rate of secondary procedure, readmission rate, early mobilization, average change of pre- to one year post-operative functional status, use of multimodal analgesia, use of neuraxial anesthesia, use of peri-articular injection in TKA, and use of pre-operative PO analgesia. CONCLUSION: This study is an expert opinion based on parameters observed in modern and high-quality academic settings. Twelve QIs are proposed to assess the quality of care in the peri-operative management of primary elective THA and TKA patients.

International primary knee arthroplasty registry review: findings from current reports.

INTRODUCTION: International joint registries provide high volumes of information in relation to the performance of total knee arthroplasty on a global scale. Distillation of this data can be challenging, particularly with the establishment of more arthroplasty registries on a yearly basis. We therefore aim to present key information from these registries in relation to primary total knee arthroplasty. The specific questions of interest include: Which fixation type is superior in TKA? Does the level of constraint impact on clinical performance? How do partial knee replacements perform in the registries? Does patellar resurfacing lead to superior results? Are there any specific implants which perform particularly well or poorly? METHODS: A comprehensive review of the major English-speaking knee arthroplasty registries across the globe was performed. Given the expanding large number of registries worldwide, it was not possible to perform a comprehensive review of all registries and so, a detailed review of the major English-speaking knee arthroplasty registries was included. Key trends and developments in implant performance were identified and presented in the current article. RESULTS: Total knee replacements have lower revision rates than both unicompartmental and patellofemoral joint replacement procedures. Patellofemoral joint replacements have the highest failure rate of all knee replacement procedures. Cruciate-Retaining (CR) TKR designs have superior outcomes to Posterior-Stabilized (PS) designs across all registries. Patellar resurfacing appears to confer an advantage over non-resurfaced patellas in primary TKR. CONCLUSION: We present current global trends in the utility and performance of TKA based on data from English-speaking arthroplasty registries.

The Impact of Changing Total Knee Arthroplasty Implants at a High-Volume Institution.

BACKGROUND: The ability of a group of high-volume arthroplasty surgeons to simultaneously change their preferred primary total knee arthroplasty (TKA) implant of choice to another, has not been explored in the literature to date. The main hypothesis was that such a change could be made with no significant impact on clinical outcomes. METHODS: This is a retrospective cohort study comparing the last 500 consecutive TKAs implanted of a routinely used TKA implant (NexGen; Zimmer, Warsaw, IN) with the first 500 consecutive TKAs implanted of a newly adopted TKA implant (Triathlon; Stryker, Mahwah, NJ) at an institutional level. Primary outcomes of importance included all complications that occurred either intraoperatively or early postoperatively, early all-cause revision rate, and early reintervention rate. RESULTS: There was a 1.2% (n = 6) complication rate in the NexGen cohort compared to 0.8% (n = 4) in the newly adopted Triathlon cohort (P = .75). The rate of intraoperative fracture was 1% in the NexGen cohort and 0.6% in the Triathlon cohort (P = .72). The early all-cause revision rate for the NexGen TKA was 1% (n = 5) compared to 0.8% (n = 4) in the Triathlon cohort (P = 1.0). The manipulation under anesthesia (MUA) rate in the NexGen cohort was 2.4% compared to 4.6% in the Triathlon cohort (P = .058). The only predictor variable associated with MUA rate was American Society of Anesthesiologists grade, where there was a significantly lower rate of MUA with a higher American Society of Anesthesiologists grade (P = .042). CONCLUSION: It is possible to implement the institution-wide adoption of an established, high-performing TKA implant without any negative implications in relation to early revision rates, perioperative complication rates, and reintervention rates. This study is the first of its kind to be reported in the literature.

Minimally Invasive Intermuscular Approaches Versus Conventional Approaches in Total Hip Arthroplasty: A Systematic Review and Meta-Analysis.

BACKGROUND: To date, the literature has not yet revealed superiority of Minimally Invasive (MI) approaches over conventional techniques. We performed a systematic review to determine whether minimally invasive approaches are superior to conventional approaches in total hip arthroplasty for clinical and functional outcomes. We performed a meta-analysis of level 1 evidence to determine whether minimally invasive approaches are superior to conventional approaches for clinical outcomes. METHODS: All studies comparing MI approaches to conventional approaches were eligible for analysis. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were adhered to throughout this study. Registries were searched using the following MeSH terms: 'minimally invasive', 'muscle-sparing', 'THA', 'THR', 'hip arthroplasty' and 'hip replacement'. Locations searched included PubMed, the Cochrane Library, ClinicalTrials.gov, the European Union (EU) clinical trials register and the International Clinical Trials Registry Platform (World Health Organisation). RESULTS: Twenty studies were identified. There were 1,282 MI total hip arthroplasty (THAs) and 1,351 conventional THAs performed. There was no difference between MI and conventional approaches for all clinical outcomes of relevance including all-cause revision (P = .959), aseptic revision (P = .894), instability (P = .894), infection (P = .669) and periprosthetic fracture (P = .940). There was also no difference in functional outcome at early or intermediate follow-up between the two groups (P = .38). In level I studies exclusively, random-effects meta-analysis demonstrated no difference in aseptic revision (P = .461) and all other outcomes between both groups. CONCLUSION: Intermuscular MI approaches are equivalent to conventional THA approaches when considering all-cause revision, aseptic revision, infection, dislocation, fracture rates and functional outcomes. Meta-analysis of level 1 evidence supports this claim.

How Large a Study Is Needed to Detect TKA Revision Rate Reductions Attributable to Robotic or Navigated Technologies? A Simulation-based Power Analysis.

BACKGROUND: Robotic and navigated TKA procedures have been introduced to improve component placement precision in the hope of improving implant survivorship and other clinical outcomes. Although numerous comparative studies have shown enhanced precision and accuracy in placing components, most comparative studies have not shown that such interventions result in improved implant survival. Given what we know about effect sizes from large arthroplasty registries, large cohort studies, and large randomized controlled trials (RCTs), we wondered how large randomized trials would need to be to detect such small differences, and if the number is very high, what that would tell us about the value of these treatments for preventing revision surgery. QUESTIONS/PURPOSES: In this simulation study, we asked: Given that survivorship differences between technology-assisted TKA (TA-TKA, which we defined as either navigated or robot-assisted TKA) and conventional TKA are either small or absent based on large arthroplasty registries, large cohort studies, and large RCTs, how large would randomized trials need to be to detect small differences between TA-TKA and conventional TKA if they exist, and how long would the follow-up period need to be to have a reasonable chance to detect those differences? METHODS: We used estimated effect sizes drawn from previous clinical and registry studies, combined with estimates of the accuracy and precision of various navigation and robotic systems, to model and simulate the likely outcomes of potential comparative clinical study designs. To characterize the ranges of patients enrolled and general follow-up times associated with traditional RCT studies, we conducted a structured search of previously published studies evaluating the effect of robotics and navigation on revision rates compared with that of conventional TKA. The structured search of the University of British Columbia's library database (which automatically searches medical publication databases such as PubMed, Embase, Medline, and Web of Science) and subsequent searching through included studies' reference lists yielded 103 search results. Only clinical studies assessing implant survival differences between patient cohorts of TA-TKA and conventional TKA were included. Studies analyzing registry data, using cadaver specimens, assessing revision TKA, conference proceedings, and preprint services were excluded. Twenty studies met all our inclusion criteria, but only one study reported a statistically significant difference between the conventional and robotic or navigated groups. Next, we generated a large set of patients with simulated TKA (1.5 million), randomly assigning each simulated patient a set of patient-specific factors (age at the index surgery, gender, and BMI) drawn from data from registries and published information. We divided this set of simulated procedures into four groups, each associated with a coronal alignment precision reported for different types of surgical procedures, and randomly assigned each patient an overall coronal alignment consistent with their group's precision. TA procedures were modeled based on the alignment precision that an intervention could deliver, regardless of whether the technology used was navigation- or robot-assisted. To evaluate the power associated with using different cohort sizes, we ran a Monte Carlo simulation generating 3000 simulated populations that were drawn (with replacement) from the large set of simulated patients with TKA. We simulated the time to revision for aseptic loosening for each patient, computed the corresponding Kaplan-Meier survival curves, and applied a log-rank test to each study for statistical differences in revision rates at concurrent follow-up timepoints (1-25 years). From each simulation associated with a given cohort size, we determined the percentage of simulated studies that found a statistically significant difference at each follow-up interval. For each alternative precision, we then also calculated the expected reduction in revision rates (effect size) attributable to TA-TKA intervention and the number needed to treat (NNT) using TA-TKA to prevent one revision at 2, 5, 10, and 15 years after index surgery for the entire set of Kaplan-Meier survival analyses. RESULTS: The results from our simulation found survivorship differences favoring TA-TKA ranging from 1.4% to 2.0% at 15 years of follow-up. Comparative studies would need to enroll between 2500 and 4000 patients in each arm of the study, depending on the precision of the navigated or robotic procedure, to have an 80% chance of showing this reduction in revision rates at 15 years of follow-up. For the highest precision simulated intervention, the NNT using TA-TKA to prevent one revision was 1000 at 2 years, 334 at 5 years, 100 at 10 years, and 50 at 15 years post-index surgery. CONCLUSION: Based on these simulations, it appears that TA-TKA interventions could potentially result in a relative reduction in revision rates as large as 27% (from 7.5% down to about 5.5% at 15 years for the intervention with the most precise coronal alignment); however, since this 2% absolute reduction in revision rates is relatively small in comparison with the baseline success rate of TKA and would not be realized until 15 years after the index surgery, traditional RCT studies would require excessively large numbers of patients to be enrolled and excessively long follow-up times to demonstrate whether such a reduction actually exists. CLINICAL RELEVANCE: Given that the NNTs to avoid revisions at various time points are predicted to be high, it would require correspondingly low system costs to justify broad adoption of TA-TKA based on avoided revision costs alone, though we speculate that technology assistance could perhaps prove to be cost effective in the care of patients who are at an elevated risk of revision.

Hybrid stems are superior to cemented stems in revision total knee arthroplasty: a systematic review and meta-analysis of recent comparative studies.

INTRODUCTION: The demand for revision total knee arthroplasty (TKA) has grown significantly in recent years. The two major fixation methods for stems in revision TKA include cemented and 'hybrid' fixation. We explore the optimal fixation method using data from recent, well-designed comparative studies. METHODS: We performed a systematic review of comparative studies published within the last 10 years with a minimum follow-up of 24 months. To allow for missing data, a random-effects meta-analysis of all available cases was performed. The odds ratio (OR) for the relevant outcome was calculated with 95% confidence intervals. The effects of small studies were analyzed using a funnel plot, and asymmetry was assessed using Egger's test. The primary outcome measure was all-cause failure. Secondary outcome measures included all-cause revision, aseptic revision and radiographic failure. RESULTS: There was a significantly lower failure rate for hybrid stems when compared to cemented stems (p = 0.006) (OR 0.61, 95% CI 0.42-0.87). Heterogeneity was 4.3% and insignificant (p = 0.39). There was a trend toward superior hybrid performance for all other outcome measures including all-cause re-revision, aseptic re-revision and radiographic failure. CONCLUSION: Recent evidence suggests a significantly lower failure rate for hybrid stems in revision TKA. There is also a trend favoring the use of hybrid stems for all outcome variables assessed in this study. This is the first time a significant difference in outcome has been demonstrated through systematic review of these two modes of stem fixation. We therefore recommend the use, where possible, of hybrid stems in revision TKA.

Reliability of tibiofemoral contact area and centroid location in upright, open MRI.

BACKGROUND: Imaging cannot be performed during natural weightbearing in biomechanical studies using conventional closed-bore MRI, which has necessitated simulating weightbearing load on the joint. Upright, open MRI (UO-MRI) allows for joint imaging during natural weightbearing and may have the potential to better characterize the biomechanical effect of tibiofemoral pathology involving soft tissues. However open MRI scanners have lower field strengths than closed-bore scanners, which limits the image quality that can be obtained. Thus, there is a need to establish the reliability of measurements in upright weightbearing postures obtained using UO-MRI. METHODS: Knees of five participants with prior anterior cruciate ligament (ACL) rupture were scanned standing in a 0.5 T upright open MRI scanner using a 3D DESS sequence. Manual segmentation of cartilage regions in contact was performed and centroids of these contact areas were automatically determined for the medial and lateral tibiofemoral compartments. Inter-rater, test-retest, and intra-rater reliability were determined and quantified using intra-class correlation (ICC3,1), standard error of measurement (SEM), and smallest detectable change with 95% confidence (SDC95). Accuracy was assessed by using a high-resolution 7 T MRI as a reference. RESULTS: Contact area and centroid location reliability (inter-rater, test-retest, and intra-rater) for sagittal scans in the medial compartment had ICC3,1 values from 0.95-0.99 and 0.98-0.99 respectively. In the lateral compartment, contact area and centroid location reliability ICC3,1 values ranged from 0.83-0.91 and 0.95-1.00 respectively. The smallest detectable change in contact area was 1.28% in the medial compartment and 0.95% in the lateral compartment. Contact area and centroid location reliability for coronal scans in the medial compartment had ICC3,1 values from 0.90-0.98 and 0.98-1.00 respectively, and in the lateral compartment ICC3,1 ranged from 0.76-0.94 and 0.93-1.00 respectively. The smallest detectable change in contact area was 0.65% in the medial compartment and 1.41% in the lateral compartment. Contact area was accurate to within a mean absolute error of 11.0 mm2. CONCLUSIONS: Knee contact area and contact centroid location can be assessed in upright weightbearing MRI with good to excellent reliability. The lower field strength used in upright, weightbearing MRI does not compromise the reliability of tibiofemoral contact area and centroid location measures.

Pseudotumors and High-Grade Aseptic Lymphocyte-Dominated Vasculitis-Associated Lesions Around Total Knee Replacements Identified at Aseptic Revision Surgery: Findings of a Large-Scale Histologic Review.

BACKGROUND: Aseptic lymphocyte-dominated vasculitis-associated lesion (ALVAL) development (including pseudotumors) secondary to metal debris generation around total hip arthroplasties is a well-recognized histopathologic phenomenon. Emerging data have highlighted a similar potential concern around TKAs although the body-of-knowledge has largely been limited to individual case reports or small retrospective case series. This study sought to establish the prevalence of pseudotumors or high-grade ALVALs seen at the revision of primary TKAs and to establish the correlation between histologic ALVAL grade and patient-reported functional outcome measures. METHODS: The findings of 321 non-infective (aseptic) patients undergoing unilateral revision knee surgery, at a high-volume tertiary referral center, were reviewed. Each case was independently histologically classified. Complete patient-reported functional outcome measures were available for 134 patients (42%) allowing correlation between functional performance and histopathology results. RESULTS: Five distinct pseudotumors and a further 18 high-grade ALVALs were histologically identified representing 1.6% and 5.6% of the cohort, respectively. When compared by histologic grade, Oxford Knee Score and Western Ontario and McMaster University's Osteoarthritis Index suggested a high correlation between ALVAL grade and functional knee scores. CONCLUSION: These findings suggest a prevalence of pseudotumors or high-grade ALVALs at revision TKA surgery of >7%. This unexpectedly high result may contribute insight into the previously under-appreciated significance of metal debris-related local tissue reactions around TKAs. The findings also demonstrate a strong near-linear inverse relationship between patient-reported clinical knee performance and the underlying histologic grade of local tissue reaction. These results have potential management implications for patients with underperforming TKAs and should prompt consideration of an ALVAL secondary to metallosis in the differential diagnosis. LEVEL OF EVIDENCE: This is a retrospective cohort study with Level III evidence.

One- and two-stage surgical revision of peri-prosthetic joint infection of the hip: a pooled individual participant data analysis of 44 cohort studies.

One-stage and two-stage revision strategies are the two main options for treating established chronic peri-prosthetic joint infection (PJI) of the hip; however, there is uncertainty regarding which is the best treatment option. We aimed to compare the risk of re-infection between the two revision strategies using pooled individual participant data (IPD). Observational cohort studies with PJI of the hip treated exclusively by one- or two-stage revision and reporting re-infection outcomes were retrieved by searching MEDLINE, EMBASE, Web of Science, The Cochrane Library, and the WHO International Clinical Trials Registry Platform; as well as email contact with investigators. We analysed IPD of 1856 participants with PJI of the hip from 44 cohorts across four continents. The primary outcome was re-infection (recurrence of infection by the same organism(s) and/or re-infection with a new organism(s)). Hazard ratios (HRs) for re-infection were calculated using Cox proportional frailty hazards models. After a median follow-up of 3.7 years, 222 re-infections were recorded. Re-infection rates per 1000 person-years of follow-up were 16.8 (95% CI 13.6-20.7) and 32.3 (95% CI 27.3-38.3) for one-stage and two-stage strategies respectively. The age- and sex-adjusted HR of re-infection for two-stage revision was 1.70 (0.58-5.00) when compared with one-stage revision. The association remained consistently absent after further adjustment for potential confounders. The HRs did not vary importantly in clinically relevant subgroups. Analysis of pooled individual patient data suggest that a one-stage revision strategy may be as effective as a two-stage revision strategy in treating PJI of the hip.

Frank Stinchfield Award: Identification of the At-risk Genotype for Development of Pseudotumors Around Metal-on-metal THAs.

BACKGROUND: Once touted as the future of hip arthroplasty, metal-on-metal (MoM) bearing surfaces have fallen sharply from favor with the emergence of a strong body of evidence demonstrating unacceptably high premature implant failure rates. The previously unpredictable development of adverse local tissue reactions (ALTRs) has been a substantive contributor to this. Although the underlying pathophysiology of these so-called "pseudotumors" is now well understood, the fundamental predisposing patient risk factors have remained elusive. QUESTIONS/PURPOSES: The aim of this research, as a clinical-genotype correlation analysis, was to identify specific alleles (genes) associated with the development of ALTRs in patients with in situ MoM THAs. METHODS: A case-control study of patients who received a large-head, primary MoM THA between 2005 and 2008 was performed with a minimum followup of 5 years. Twenty-six patients who had undergone revision of a primary MoM THA secondary to symptomatic ALTRs were recruited. The mean timeframe from primary MoM THA to symptomatic revision was 5.5 years (range, 1-10 years). Twenty-eight control subjects were randomly selected asymptomatic patients with no evidence of ALTRs on protocol-specific screening. Baseline demographics and high-resolution genotype (human leukocyte antigen [HLA] Class II) were collected for all patients. Cohorts were similar with respect to age at the time of primary MoM THA (mean, 54.8 versus 54.9 years, p = 0.95) and serum cobalt (mean, 5.5 versus 8.5 µg/L, p = 0.09) and chromium concentrations (mean, 2.9 versus 4.2 µg/L, p = 0.27). The association between genotype and revision surgery secondary to ALTRs was determined with gender as a covariate. RESULTS: The prevalence of the risk genotype was 30% (16 of 54) among the entire cohort. Adjusting for sex, the odds of revision were 6.1 times greater among patients with the risk genotype present than among patients without (95% confidence interval [CI], 1.5-25.4; p = 0.01). Among females, the specificity of the risk genotype was 1.0 (95% CIexact, 0.5-1.0; pexact = 0.03), and for males, it was 0.8 (95% CIexact, 0.6-0.9; pexact < 0.01). CONCLUSIONS: The findings of this study suggest that, among patients with a primary MoM THA, allelic variation within the HLA Class II loci may be a strong, independent risk factor associated with the need for subsequent revision surgery secondary to pseudotumor formation. CLINICAL RELEVANCE: Given the hypothesis-generating nature of this novel undertaking, confirmatory prospective clinical studies are required to further elucidate this correlation and to explore the clinical utility of targeted genetic screening in this specific population. This research may, however, represent a key missing piece in the puzzle that is metal ion-induced pseudotumor formation.

A Comparison of Mobile and Fixed-Bearing Unicompartmental Knee Arthroplasty at a Minimum 10-Year Follow-up.

BACKGROUND: The long-term survivorship and functional outcomes of the mobile-bearing (MB) compared to the fixed-bearing (FB) unicompartmental knee arthroplasty (UKA) implant design remain a topic of debate. The aim of the current study was to compare the survivorship and functional outcomes of MB and FB UKA at a minimum 10-year follow-up. METHODS: We retrospectively reviewed 106 consecutive medial UKAs (89 patients) from our institution with a minimum 10-year follow-up. The 38 MB and 68 FB knees had follow-up of 14.2 years (12.9-15.5) and 11.5 years (10.2-15.1), respectively. Validated patient-reported outcomes and radiographs were evaluated as were etiology, timing, and complexity of revision. Kaplan-Meier 10-year survival was calculated with revision to total knee arthroplasty as the end point. RESULTS: The 10-year survival was 82.9% (95% confidence interval [CI] 65.8-91.9) for MB and 90.9% (95% CI 79.4-96.2) for FB UKA (P = .102), and 88.0% (95% CI 79.3-93.2) for the entire cohort. Patient outcomes were similar between groups, as were timing and etiologies for revision to total knee arthroplasty. One-third of revisions required either stems or tibial augments, and of these, all were of MB design. CONCLUSION: Survival and functional outcomes were similar between MB and FB designs. One-third of revisions required either stems or augments, all were of MB design.

An Early Report of the Use of a Modular Dual Mobility Articulation in Revision Acetabular Reconstruction.

BACKGROUND: Instability remains one of the main problems after revision hip surgery. The aim of this study was to review the clinical, radiological, and patient-reported outcomes with the use of modular dual-mobility articulation for revision acetabular reconstruction and investigate the risk of fretting corrosion by measuring serum trace metal ion levels. METHODS: Sixty consecutive patients with a minimum of 24-month follow-up after the insertion of a modular dual-mobility (Stryker, Mahwah, NJ) cup at the time of revision hip surgery were identified. Follow-up included clinical and radiological patient review and functional outcome measures, and a subset of patients had their metal ion (cobalt and chromium) levels checked. RESULTS: At the most recent follow-up, 5 patients had died, 3 patients have been revised because of ongoing instability, and 3 patients have had revision surgery due to infection. Overall functional outcome (mean Western Ontario and McMaster Universities Osteoarthritis Indexfunction 76, University of California, Los Angeles 5.6, mean Oxford 74.7, Short Form-12 physical 41.6/mental 53.3) and overall pain relief (mean Western Ontario and McMaster Universities Osteoarthritis Index pain score 78.3) scores were good. The mean satisfaction score was 78 of 100. The median serum trace metal chromium and cobalt levels at the most recent follow-up were 0.4 µg/L (range 0.1-6.1 µg/L) and 0.42 µg/L (range 0.21-9.42 µg/L), respectively. The survival with revision as the end point was 90%. CONCLUSIONS: Dual-mobility cups with modularity represent an excellent option for the patient having revision hip surgery at high risk of instability. This series presents good patient-reported outcome measures and a low complication and revision rate.