BackgroundThe number of revisions after TKA is expected to rise because of aging populations in many countries and because patients are undergoing TKA at younger ages. Aseptic loosening is a major reason for late revision, which can be predicted by radiostereometric analysis (RSA) of small groups of patients at 2 years of follow-up. RSA is therefore an ideal tool to assess new TKA designs before they are introduced to the market, although not every TKA design has been studied with RSA. If RSA-tested TKA designs have lower 10-year revision rates in national registries than non-RSA-tested TKA designs, RSA testing of all new designs could be advocated.Questions/purposesIn this study, we asked: Is there a difference in the all-cause revision rate between non-RSA-tested and RSA-tested TKA designs registered in national knee arthroplasty registries at 5 and 10 years of follow-up?MethodsKnee arthroplasty registries were identified through the European Federation of National Associations of Orthopaedics and Traumatology webpage and through a manual internet search. Inclusion criteria were a minimum follow-up duration of 10 years and available revision or survival data per TKA design. Twenty-six registries were identified; seven were included comprising 339 TKA designs, of which 236 designs were classified as RSA-tested and 103 as non-RSA-tested. Six registries were excluded because no report was published. One registry was excluded because no fixation method was mentioned (79 TKA designs). Another registry was excluded because there was no 10-year data available (22 non-RSA-tested designs; 10 RSA-tested designs). Eleven registries were excluded because they did not provide revision rates per design and had not reached 10 years follow-up. The revision rates with their standard errors were extracted per design. We used the data from a recent meta-analysis to identify whether a TKA design was previously tested with RSA. This meta-analysis found 53 RSA studies comprising 70 different TKA designs. The prosthesis model, fixation method and insert type were extracted from these RSA-studies. The design characteristics of the TKA reported in the knee arthroplasty registries were also extracted, and if possible, matched to the TKA designs reported in the RSA-studies. At 5 years of follow-up, 191 TKA designs were identified as non-RSA-tested and 92 were identified as RSA-tested. At 10 years of follow-up, 154 TKA designs and 74 TKA designs were classified as non-RSA-tested and RSA-tested, respectively. A random-effects model using the Metafor Package in R statistics was used to estimate the pooled revision rate at 5 and 10 years of follow-up for both groups. The difference in revision rates between groups at 5 and 10 years of follow-up was estimated by including RSA as a factor in the random-effects model.ResultsMean all-cause revision rates at 5 years for non-RSA-tested and RSA-tested implants were 3.6% (95% CI 3.4 to 3.8) and 2.9% (95% CI 2.7 to 3.0), with a mean difference of 0.6% favoring RSA-tested implants (95% CI 0.4 to 0.8; p < 0.001). Mean all-cause revision rates at 10 years for non-RSA-tested and RSA-tested implants were 5.5% (95% CI 5.2 to 5.9) and 4.4% (95% CI 4.1 to 4.7), with a mean difference of 0.9% favoring RSA-tested implants (95% CI 0.4 to 1.3; p < 0.001).ConclusionsAlthough there are exceptions, across registries, TKA designs that have been tested in an RSA setting have a slightly lower (about 1%) mean all-cause revision rate at 5-year and 10-year follow-up than those tested in a non-RSA setting. Acknowledging the inherent limitations of this observational study, a risk difference of 1% could potentially translate into an approximate 20% decrease in revision burden up to 10 years, which may have a profound impact on patient morbidity and health-related costs.Level of EvidenceLevel III, therapeutic study.@en

Background: It is unclear whether there are differences in benefits and harms between mobile and fixed prostheses for total knee arthroplasty (TKA). The previous Cochrane review published in 2004 included two articles. Many more trials have been performed since then; therefore an update is needed. Objectives: To assess the benefits and harms of mobile bearing compared with fixed bearing cruciate retaining total knee arthroplasty for functional and clinical outcomes in patients with osteoarthritis (OA) or rheumatoid arthritis (RA). Search methods: We searched The Cochrane Library, PubMed, EMBASE, CINAHL and Web of Science up to 27 February 2014, and the trial registers ClinicalTrials.gov, Multiregister, Current Controlled Trials and the World Health Organization (WHO) International Clinical Trials Registry Platform for data from unpublished trials, up to 11 February 2014. We also screened the reference lists of selected articles. Selection criteria: We selected randomised controlled trials comparing mobile bearing with fixed bearing prostheses in cruciate retaining TKA among patients with osteoarthritis or rheumatoid arthritis, using functional or clinical outcome measures and follow-up of at least six months. Data collection and analysis: We used standard methodological procedures as expected by The Cochrane Collaboration. Main results: We found 19 studies with 1641 participants (1616 with OA (98.5%) and 25 with RA (1.5%)) and 2247 knees. Seventeen new studies were included in this update. Quality of the evidence ranged from moderate (knee pain) to low (other outcomes). Most studies had unclear risk of bias for allocation concealment, blinding of participants and personnel, blinding of outcome assessment and selective reporting, and high risk of bias for incomplete outcome data and other bias. Knee pain We calculated the standardised mean difference (SMD) for pain, using the Knee Society Score (KSS) and visual analogue scale (VAS) in 11 studies (58%) and 1531 knees (68%). No statistically significant differences between groups were reported (SMD 0.09, 95% confidence interval (CI) -0.03 to 0.22, P value 0.15). This represents an absolute risk difference of 2.4% points higher (95% CI 0.8% lower to 5.9% higher) on the KSS pain scale and a relative percent change of 0.22% (95% CI 0.07% lower to 0.53% higher). The results were homogeneous. Clinical and functional scores The KSS clinical score did not differ statistically significantly between groups (14 studies (74%) and 1845 knees (82%)) with a mean difference (MD) of -1.06 points (95% CI -2.87 to 0.74, P value 0.25) and heterogeneous results. KSS function was reported in 14 studies (74%) with 1845 knees (82%) as an MD of -0.10 point (95% CI -1.93 to 1.73, P value 0.91) and homogeneous results. In two studies (11%), the KSS total score was favourable for mobile bearing (159 vs 132 for fixed bearing), with MD of -26.52 points (95% CI -45.03 to -8.01, P value 0.005), but with a wide 95% confidence interval indicating uncertainty about the estimate. Other reported scoring systems did not show statistically significant differences: Hospital for Special Surgery (HSS) score (seven studies (37%) in 1021 knees (45%)) with an MD of -1.36 (95% CI -4.18 to 1.46, P value 0.35); Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score (two studies (11%), 167 knees (7%)) with an MD of -4.46 (95% CI -16.26 to 7.34, P value 0.46); and Oxford total (five studies (26%), 647 knees (29%) with an MD of -0.25 (95% CI -1.41 to 0.91, P value 0.67). Health-related quality of life Three studies (16%) with 498 knees (22%) reported on health-related quality of life, and no statistically significant differences were noted between the mobile bearing and fixed bearing groups. The Short Form (SF)-12 Physical Component Summary had an MD of -1.96 (95% CI -4.55 to 0.63, P value 0.14) and heterogeneous results. Revision surgery Twenty seven revisions (1.3%) were performed in 17 studies (89%) with 2065 knees (92%). In all, 13 knees were revised in the fixed bearing group and 14 knees in the mobile bearing group. No statistically significant differences were found (risk difference 0.00, 95% CI -0.01 to 0.01, P value 0.58), and homogeneous results were reported. Mortality In seven out of 19 studies, 13 participants (37%) died. Two of these participants had undergone bilateral surgery, and for seven participants, it was unclear which prosthesis they had received; therefore they were excluded from the analyses. Thus our analysis included four out of 191 participants (2.1%) who had died: one in the fixed bearing group and three in the mobile bearing group. No statistically significant differences were found. The risk difference was -0.02 (95% CI -0.06 to 0.03, P value 0.49) and results were homogeneous. Reoperation rates Thirty reoperations were performed in 17 studies (89%) with 2065 knees (92%): 18 knees in the fixed bearing group (of the 1031 knees) and 12 knees in the mobile group (of the 1034 knees). No statistically significant differences were found. The risk difference was -0.01 (95% CI -0.01 to 0.01, P value 0.99) with homogeneous results. Other serious adverse events Sixteen studies (84%) reported nine other serious adverse events in 1735 knees (77%): four in the fixed bearing group (of the 862 knees) and five in the mobile bearing group (of the 873 knees). No statistically significant differences were found (risk difference 0.00, 95% CI -0.01 to 0.01, P value 0.88), and results were homogeneous. Authors' conclusions: Moderate- to low-quality evidence suggests that mobile bearing prostheses may have similar effects on knee pain, clinical and functional scores, health-related quality of life, revision surgery, mortality, reoperation rate and other serious adverse events compared with fixed bearing prostheses in posterior cruciate retaining TKA. Therefore we cannot draw firm conclusions. Most (98.5%) participants had OA, so the findings primarily reflect results reported in participants with OA. Future studies should report in greater detail outcomes such as those presented in this systematic review, with sufficient follow-up time to allow gathering of high-quality evidence and to inform clinical practice. Large registry-based studies may have added value, but they are subject to treatment-by-indication bias. Therefore, this systematic review of RCTs can be viewed as the best available evidence.@en