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

Abstract

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 rate of Birmingham Hip Resurfacing arthroplasty: comparison of published literature and arthroplasty register data

“…Recent attention has focused on the difference of outcome between revision rate reported in the peerreviewed literature and those in national joint arthroplasty registers. Findings were similar to those of our study for implants used in either field: THA, total knee arthroplasty, or total ankle arthroplasty [5][6][7][46][47][48][49][50].…”

“…Also, the evaluation procedures applied, such as designation of implant variants to cohorts, may potentially lead to misinterpretations [6]. Registers focus on outcome concerning revision rate, as do most of outcome studies related to specific implants [7]. The issue of uncontrollable factors, such as the impact of individual interests, the impact on the results of clinical sample-based studies of specific study circumstances, or the occurrence of publication bias are still part of the scientific discussion.…”

Consecutive series of 226 journey bicruciate substituting total knee replacements: early complication and revision rates

“…The rate of 1.65 major revisions per 100 observed component years documented in the study is high in comparison to the published rates for established knee systems. Schuh et al have recently shown average TKR revision rates of 3.24% in European literature, 1.74% in US literature, and 3.33% in register-based studies[ 19 ], which correspond to 0.64, 0.16, and 0.51 revisions per 100 observed component years respectively[ 19 ]. The latest annual report of the National Joint Replacement Registry of the Australian Orthopaedic Association from 2012 showed 1.79 revisions (95% confidence limits 1.47-2.15) per 100 observed component years for the Journey prosthesis, which was the highest rate seen for a prosthesis with cement fixation[ 20 ].…”

The outcome of the cementless tapered SL-Plus stem: an analysis of arthroplasty register data

“…Arthroplasty register datasets in general show superior quality compared to metanalyses of clinical studies, but some specific requirements should be taken into consideration for interpretation [8,9].…”