Revision surgery after total joint arthroplasty: a complication-based analysis using worldwide arthroplasty registers.

The authors performed a complication-based analysis of total knee (TKA), total hip (THA), and total ankle arthroplasty (TAA) using worldwide arthroplasty registers. We extracted data with respect to reason for revision surgery and pooled causes. The most common causes for revisions in THA were aseptic loosening (55.2%), dislocation (11.8 %), septic loosening (7.5%), periprosthetic fractures (6%), and others. The most common causes in TKA were aseptic loosening (29.8%), septic loosening (14.8%), pain (9.5%), wear (8.2%), and others. The most common causes in TAA were aseptic loosening (38%), technical errors (15%), pain (12%), septic loosening (9.8%), and others. Revisions in TKA and THA differ with respect to type of complication. However, in case of TAA, higher rates of technically related complications are reported.

Pooled outcome of total hip arthroplasty with the CementLess Spotorno (CLS) system: a comparative analysis of clinical studies and worldwide arthroplasty register data.

PURPOSE: Our aim was to elucidate the pooled outcome of the CementLess Spotorno (CLS) system in total hip arthroplasty (THA). METHODS: We compared the outcome of clinical inventor studies, independent clinical studies, and worldwide register data. The main endpoints for analysis were revision rates. RESULTS: Twenty clinical studies were evaluated and, with one exception, overall found revision rates largely in line with register data. Revision rates (revisions per 100 observed component years) range from 0.15 (inventor study) to 0.28 (independent studies) and 0.43 (register datasets). CONCLUSION: Data of journal publications and register datasets using the CLS system do not differ significantly with respect to revision rates. Only the initial inventor study reports a revision rate three times lower than in pooled worldwide register datasets.

Validity of published outcome data concerning Anatomic Graduated Component total knee arthroplasty: a structured literature review including arthroplasty register data.

PURPOSE: Total knee arthroplasty (TKA) as a treatment for end-stage osteoarthritis of the knee shows good results in terms of patient satisfaction. For the assessment of outcome and revision rate after total joint arthroplasty, there are two major data sources: clinical studies and national arthroplasty registers. The purpose of this study was to analyse the outcome of Anatomic Graduated Component (AGC) TKA reported in clinical studies and to perform a comparison with the outcome reported by national arthroplasty registers. METHODS: A systematic literature review was performed using standardised methodology in order to determine the outcome and revision rate of AGC TKA. In a comprehensive meta-analysis of clinical studies and worldwide register results we examined the quality of the basic data and the occurrence and influence of potential bias factors. Confidence intervals were calculated to determine the statistical significance of differences. RESULTS: We found significant differences as regards the revision rate measured in revisions per 100 observed component years. Compared to worldwide register data it turned out to be significantly lower in clinical studies published by the implant development team. Actually, they reported a revision rate of 0.18 revisions per 100 observed component years, whereas annual reports of national arthroplasty registers report 0.74 revisions per 100 observed component years. A comparison of the results from national arthroplasty registers of different countries revealed a significantly higher revision rate for Denmark in relation to worldwide register data. CONCLUSIONS: A conventional meta-analysis of clinical studies is affected by the influence of the development team and therefore subject to bias. For the assessment of outcome arthroplasty register data should be rated as superior and, being used as reference data for the detection of potential bias factors in the clinical literature, could make an essential contribution to the quality of scientific meta-analysis.

Revision rates after total ankle arthroplasty in sample-based clinical studies and national registries.

BACKGROUND: The aim of this study was to evaluate the outcome of specific implants in total ankle arthroplasty as reported in clinical studies and determined by national registries. MATERIALS AND METHODS: A structured literature review was conducted regarding sample-based clinical studies and national registry data. To allow for comparative analyses, registry data had to be available for the implants included. These were STAR Ankle, Büchel-Pappas, Hintegra, Mobility, Agility, and Ramses Total Ankle Arthroplasty. The revision rate was used as the main outcome parameter. RESULTS: On average, the revision rates published in sample-based clinical studies were about half the value found in registries. Implant developers represent a share of almost 50% of the published content and are therefore over-represented in scientific publications. The inventors of STAR Ankle and BP total ankle implants published data which was statistically significantly superior to the outcome achieved in average patients as documented in registries. Irrespective of the implant, the average revision rate to be expected according to the registry data available is 21.8% after 5 years, and 43.5% after 10 years. CONCLUSION: The average revision rate published in peer-reviewed scientific articles was significantly lower than the outcome achieved according to national arthroplasty registry data, which reflect actual average patient care in the respective countries. Publications by some research groups, particularly by implant inventors, show a deviation from the outcome published by other users and those shown in registry data.

Organisation, data evaluation, interpretation and effect of arthroplasty register data on the outcome in terms of revision rate in total hip arthroplasty.

Originally developed in Scandinavia, national arthroplasty registers have spread worldwide during the last decade. The value of registers for quality improvement in arthroplasty has frequently been documented. However, for the development of a successful register a few key points should be taken into account. Uncontrolled loss of patients from the registry area should be avoided. Registers should form an integral part of a country's medical system. To realise the potential for improvement, it is crucial that physicians deal with the results in detail. Thus it is absolutely essential to involve the specialty societies in the interpretation and dissemination of results. With respect to revision rates, register data are usually more valid than meta-analyses of clinical studies. For every physician the most valuable data are those coming from a register in his own country; the development of national arthroplasty registers should therefore be continued.

Impact of implant developers on published outcome and reproducibility of cohort-based clinical studies in arthroplasty.

BACKGROUND: The reproducibility of the results of cohort-based clinical studies of arthroplasty procedures by the average orthopaedic surgeon is a major issue involving the quality of the scientific literature. We compared the results of a comprehensive literature analysis with data from national arthroplasty registries to examine the influence of arthroplasty implant inventors on the outcomes published in peer-reviewed journals. METHODS: A structured review of the literature published in MEDLINE-listed journals was performed. A comparison of the average revision rates in the identified studies (adjusted for the number of arthroplasty cases and the duration of follow-up) with the registry data was then conducted. RESULTS: Seventeen of the analyzed arthroplasty implants were developed in the United States. Studies by the developers of these implants often had a substantial influence on the published outcome. For approximately 50% of the implant systems analyzed, the average revision rate derived by combining all published studies showed a statistically significant and clinically relevant deviation from the revision rate derived from the arthroplasty registry data, which reflected the outcome in the average patient. For the majority of implants for which the revision rate calculated from the published clinical studies was very low compared with the rate calculated from the registry data, the developing institution accounted for 39% to 100% of the published outcome data for the implant. In contrast, the published results were usually reproducible in clinical practice if <25% of the published data were reported by the developers. Three of the nine arthroplasty implants developed in Europe showed a significant and clinically relevant difference between the revision rate derived from only the studies published by the developers and the rate calculated from the registry data. However, because of the considerably greater amount of data from independent studies that was typically available for the European implants than for the American implants, studies by the developer that deviated significantly from the registry data could usually also be identified as outliers by a meta-analysis of all published studies. A high proportion of the published data involving three of the European implants was reported by the inventors, but comparison with the registry data revealed that the average published revision rates for two of these three implants were reproducible in clinical practice. CONCLUSIONS: The published results of the clinical studies involving many of the arthroplasty implants, especially implants developed in the United States, were highly influenced by reports from the center that developed the implant. This often had a substantial effect on the reproducibility of the outcome data. There appeared to be relevant differences between the medical research systems in Europe and the United States that also affected the reproducibility and applicability of the results for the average surgeon. Registry data can contribute substantial added value to an informed discussion of arthroplasty outcomes.