Bart G Pijls

Early migration of tibial components is associated with late revision: a systematic review and meta-analysis of 21,000 knee arthroplasties.

Purpose We performed two parallel systematic reviews and meta-analyses to determine the association between early migration of tibial components and late aseptic revision. Methods One review comprised early migration data from radiostereometric analysis (RSA) studies, while the other focused on revision rates for aseptic loosening from long-term survival studies. Thresholds for acceptable and unacceptable migration were determined according to that of several national joint registries: < 5% revision at 10 years. Results Following an elaborate literature search, 50 studies (involving 847 total knee prostheses (TKPs)) were included in the RSA review and 56 studies (20,599 TKPs) were included in the survival review. The results showed that for every mm increase in migration there was an 8% increase in revision rate, which remained after correction for age, sex, diagnosis, hospital type, continent, and study quality. Consequently, migration up to 0.5 mm was considered acceptable during the first postoperative year, while migration of 1.6 mm or more was unacceptable. TKPs with migration of between 0.5 and 1.6 mm were considered to be at risk of having revision rates higher than 5% at 10 years. Interpretation There was a clinically relevant association between early migration of TKPs and late revision for loosening. The proposed migration thresholds can be implemented in a phased, evidence-based introduction of new types of knee prostheses, since they allow early detection of high-risk TKPs while exposing only a small number of patients.

RSA and Registries: The Quest for Phased Introduction of New Implants

INTRODUCTION Although the overall survival of knee and hip prostheses at ten years averages 90%, recent problems with several hip and knee prostheses have illustrated that the orthopaedic community, industry, and regulators can still further improve patient safety. Given the early predictive properties of roentgen stereophotogrammetric analysis (RSA) and the meticulous follow-up of national joint registries, these two methods are ideal tools for such a phased clinical introduction. In this paper, we elaborate on the predictive power of RSA within a two-year follow-up after arthroplasty and its relationship to national joint registries. The association between RSA prosthesis-migration data and registry data is evaluated. METHODS The five-year rate of revision of RSA-tested total knee replacements was compared with that of non-RSA-tested total knee replacements. Data were extracted from the published results of the national joint registries of Sweden, Australia, and New Zealand. RESULTS There was a 22% to 35% reduction in the number of revisions of RSA-tested total knee replacements as compared with non-RSA-tested total knee replacements in the national joint registries. Assuming that the total cost of total knee arthroplasty is

Early proximal migration of cups is associated with late revision in THA: A systematic review and meta-analysis of 26 RSA studies and 49 survival studies

37,000 in the United States, a 22% to 35% reduction in the number of revisions (currently close to 55,000 annually) could lead to an estimated annual savings of over

A systematic review and meta-regression of mobile-bearing versus fixed-bearing total knee replacement in 41 studies.

400 million to the health-care system. CONCLUSION The phased clinical introduction of new prostheses with two-year RSA results as a qualitative tool could lead to better patient care and could reduce the costs associated with revision total knee arthroplasty. Follow-up in registries is necessary to substantiate these results and to improve post-market surveillance.

Revision surgery is overestimated in hip replacement

This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the source is credited.Background and purpose The association between excessive early migration of acetabular cups and late aseptic revision has been scantily reported. We therefore performed 2 parallel systematic reviews and meta-analyses to determine the association between early migration of acetabular cups and late aseptic revision. Methods One review covered early migration data from radiostereometric analysis (RSA) studies, while the other focused on revision rates for aseptic loosening from long-term survival studies. Thresholds for acceptable and unacceptable migration were classified according the Swedish Hip Arthroplasty Register and the Australian National Joint Replacement Registry: < 5% revision at 10 years. Results Following an elaborate literature search, 26 studies (involving 700 cups) were included in the RSA review and 49 studies (involving 38,013 cups) were included in the survival review. For every mm increase in 2-year proximal migration, there was a 10% increase in revision rate, which remained after correction for age, sex, diagnosis, hospital type, continent, and study quality. Consequently, proximal migration of up to 0.2 mm was considered acceptable and proximal migration of 1.0 mm or more was considered unacceptable. Cups with proximal migration of between 0.2 and 1.0 mm were considered to be at risk of having revision rates higher than 5% at 10 years. Interpretation There was a clinically relevant association between early migration of acetabular cups and late revision due to loosening. The proposed migration thresholds can be implemented in a phased evidence-based introduction, since they allow early detection of high-risk cups while exposing a small number of patients.

The beneficial effect of hydroxyapatite lasts: a randomized radiostereometric trial comparing hydroxyapatite-coated, uncoated, and cemented tibial components for up to 16 years.

Mobile-bearing (MB) total knee replacement (TKR) was introduced to reduce the risk of aseptic loosening and wear of polyethylene inserts. However, no consistent clinical advantages of mobile- over fixed-bearing (FB) TKR have been found. In this study we evaluated whether mobile bearings have an advantage over fixed bearings with regard to revision rates and clinical outcome scores. Furthermore, we determined which modifying variables affected the outcome. A systematic search of the literature was conducted to collect clinical trials comparing MB and FB in primary TKR. The primary outcomes were revision rates for any reason, aseptic loosening and wear. Secondary outcomes included range of movement, Knee Society score (KSS), Oxford knee score (OKS), Short-Form 12 (SF-12) score and radiological parameters. Meta-regression techniques were used to explore factors modifying the observed effect. Our search yielded 1827 publications, of which 41 studies met our inclusion criteria, comprising over 6000 TKRs. Meta-analyses showed no clinically relevant differences in terms of revision rates, clinical outcome scores or patient-reported outcome measures between MB and FB TKRs. It appears that theoretical assumptions of superiority of MB over FB TKR are not borne out in clinical practice.

All-polyethylene Tibial Components are Equal to Metal-backed Components: Systematic Review and Meta-regression

Objectives The Kaplan-Meier estimation is widely used in orthopedics to calculate the probability of revision surgery. Using data from a long-term follow-up study, we aimed to assess the amount of bias introduced by the Kaplan-Meier estimator in a competing risk setting. Methods We describe both the Kaplan-Meier estimator and the competing risk model, and explain why the competing risk model is a more appropriate approach to estimate the probability of revision surgery when patients die in a hip revision surgery cohort. In our study, a total of 62 acetabular revisions were performed. After a mean of 25 years, no patients were lost to follow-up, 13 patients had undergone revision surgery and 33 patients died of causes unrelated to their hip. Results The Kaplan-Meier estimator overestimates the probability of revision surgery in our example by 3%, 11%, 28%, 32% and 60% at five, ten, 15, 20 and 25 years, respectively. As the cumulative incidence of the competing event increases over time, as does the amount of bias. Conclusions Ignoring competing risks leads to biased estimations of the probability of revision surgery. In order to guide choosing the appropriate statistical analysis in future clinical studies, we propose a flowchart.

Differences in long-term fixation between mobile-bearing and fixed-bearing knee prostheses at ten to 12 years' follow-up: a single-blinded randomised controlled radiostereometric trial.

Background and purpose In contrast to early migration, the long-term migration of hydroxyapatite- (HA-) coated tibial components in TKA has been scantily reported. This randomized controlled trial investigated the long-term migration measured by radiostereometric analysis (RSA) of HA-coated, uncoated, and cemented tibial components in TKA. Patients and methods 68 knees were randomized to HA-coated (n = 24), uncoated (n = 20), and cemented (n = 24) components. All knees were prospectively followed for 11–16 years, or until death or revision. RSA was used to evaluate migration at yearly intervals. Clinical and radiographic evaluation was according to the Knee Society system. A generalized linear mixed model (GLMM, adjusted for age, sex, diagnosis, revisions, and BMI) was used to take into account the repeated-measurement design. Results The present study involved 742 RSA analyses. The mean migration at 10 years was 1.66 mm for HA, 2.25 mm for uncoated and 0.79 mm for the cemented group (p < 0.001). The reduction of migration by HA as compared to uncoated components was most pronounced for subsidence and external rotation. 3 tibial components were revised for aseptic loosening (2 uncoated and 1 cemented), 3 for septic loosening (2 uncoated and 1 cemented), and 1 for instability (HA-coated). 2 of these cases were revised for secondary loosening after a period of stability: 1 case of osteolysis and 1 case of late infection. There were no statistically significant differences between the fixation groups regarding clinical or radiographic scores. Interpretation HA reduces migration of uncemented tibial components. This beneficial effect lasts for more than 10 years. Cemented components showed the lowest migration. Longitudinal follow-up of TKA with RSA allows early detection of secondary loosening.

AQUILA: assessment of quality in lower limb arthroplasty. An expert Delphi consensus for total knee and total hip arthroplasty

BackgroundLess than 1% of all primary TKAs are performed with an all-polyethylene tibial component, although recent studies indicate all-polyethylene tibial components are equal to or better than metal-backed ones.Questions/purposesWe asked whether the metal-backed tibial component was clinically superior to the all-polyethylene tibial component in primary TKAs regarding revision rates and clinical functioning, and which modifying variables affected the revision rate.MethodsWe systematically reviewed the literature for clinical studies comparing all-polyethylene and metal-backed tibial components used in primary TKAs in terms of revision rates, clinical scores, and radiologic parameters including radiostereometric analysis (RSA). Meta-regression techniques were used to explore factors modifying the observed effect. Our search yielded 1557 unique references of which 26 articles were included, comprising more than 12,500 TKAs with 231 revisions for any reason.ResultsMeta-analysis showed no differences between the all-polyethylene and metal-backed components except for higher migration of the metal-backed components. Meta-regression showed strong evidence that the all-polyethylene design has improved with time compared with the metal-backed design.ConclusionsThe all-polyethylene components were equivalent to metal-backed components regarding revision rates and clinical scores. The all-polyethylene components had better fixation (RSA) than the metal-backed components. The belief that metal-backed components are better than all-polyethylene ones seems to be based on studies from earlier TKAs. This might no longer be true for modern TKAs.Level of EvidenceLevel II, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

Which implant should we use for primary total hip replacement? A systematic review and meta-analysis.

This single-blinded randomised controlled trial investigated whether one design of mobile-bearing (MB) total knee replacement (TKR) has any advantage over a fixed-bearing (FB) design on long-term fixation as measured by radiostereometry. The amount of wear underneath the mobile bearing was also evaluated. A series of 42 knees was randomised to MB or FB tibial components with appropriate polyethylene inserts and followed for between ten and 12 years, or until the death of the patient. The polyethylene in the MB group was superior in that it was gamma-irradiated in inert gas and was calcium-stearate free; the polyethylene in the FB group was gamma-irradiated in air and contained calcium stearate. In theory this should be advantageous to the wear rate of the MB group. At final follow-up the overall mean migration was 0.75 mm (SD 0.76) in the MB group and 0.66 mm (SD 0.4) in the FB group, with the FB group demonstrating more posterior tilt and the MB group more internal rotation. In the FB group there was one revision for aseptic loosening, but none in the MB group. There were no significant differences in clinical or radiological scores. For the MB group, the mean linear wear rate on the under-surface was 0.026 mm/year (SD 0.014). This was significantly smaller than the wear rate of 0.11 mm/year (SD 0.06) in the MB between femur and polyethylene (p < 0.001). Nevertheless, even in a best-case setting the mobile bearings of this TKR design had no apparent advantage in terms of fixation over the FB knee prosthesis at ten to 12 years. The wear underneath the mobile bearing was small and is unlikely to be clinically relevant.