Article

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

Biomechanics and Imaging Group, Department of Orthopaedics, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands. Nelissen:
The Journal of Bone and Joint Surgery (Impact Factor: 5.28). 12/2011; 93 Suppl 3(Suppl 3):62-5. DOI: 10.2106/JBJS.K.00907
Source: PubMed

ABSTRACT

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.
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.
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 $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 $400 million to the health-care system.
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.

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    • "Limitations of this study are mainly due to the retrospective design of this study. Ideally, the introduction of a new prosthesis is preceded by a randomized clinical trial comparing both prostheses with extensive follow-up [24,25]. However, as the 'classic’ was no longer available, a randomized clinical trial was not an option. "
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    ABSTRACT: Long-term results of the 'classic' low contact stress (LCS) total knee replacement (TKR) have been satisfactory; nonetheless, design changes have been made which resulted in the 'complete' LCS TKR. The aim of this study is to compare the 5-year incidence of revision and midterm clinical performance before and after introduction of the 'complete'. A retrospective cohort analysis was conducted on 100 primary uncemented TKRs of both designs. At 5-year follow-up, revision and reoperation rates were determined for these 200 TKRs. Knee Society score (KSS), the Oxford Knee score (OKS) and range of motion were determined for 143 TKRs. In the 'classic' cohort, 3% of the TKRs were revised compared with 5% in the 'complete' cohort (p = 0.72).The mean KSS was 134.1 (SD 38.3) in the 'classic' cohort compared to 135.0 (SD 42.8) in the 'complete' cohort (p = 0.89). Of the 'complete' TKRs, 35.2% scored within the lowest quartile of the KSS knee compared to 16.7% of the 'classic' TKRs (p = 0.01). The OKS was 23.3 (SD 9.3) in the 'classic' cohort compared to 22.5 (SD 10.1) in the 'complete' cohort (p = 0.45). More than 5° flexion contracture was only found in four patients in the 'complete' cohort (p = 0.04). No statistical difference in revision rate and average scores for midterm clinical performance was observed between the 'classic' and the 'complete'. However, the 'complete' cohort had a higher percentage of KSS Knee in the lowest quartile, which suggests a clinical relevant difference compared with the 'classic'. Further investigation in future studies with new designs is needed.
    Full-text · Article · Feb 2014 · Journal of Orthopaedic Surgery and Research
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    • "In this systematic review, RSA studies of 20–60 patients followed for 1 year led to the same conclusion as national joint registries with thousands of patients followed for 5–10 years. A recent publication has shown a 22–35% reduction in the number of revisions of RSA-tested total knee replacements as compared to non-RSA-tested total knee replacements in the national joint registries (Nelissen et al. 2011). Because inferior designs can already be detected early postoperatively, exposing only a small group of patients to potentially unsafe TKPs, RSA provides the necessary efficiency to make possible phased, evidence-based introduction. "
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    ABSTRACT: 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.
    Full-text · Article · Nov 2012 · Acta Orthopaedica
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    • "In this systematic review, RSA studies of 10–60 patients followed for only 2 years identified the same unsafe cups (the Wagner cup and the Link V threaded cup) as did national joint registries where thousands of patients were followed for 10 years. A recent publication has shown a 22–35% reduction in the number of revisions of RSA-tested total knee replacements as compared to non-RSA-tested total knee replacements in the national joint registries (Nelissen et al. 2011). "
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    ABSTRACT: 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.
    Full-text · Article · Nov 2012 · Acta Orthopaedica
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