Abstract
Introduction: Clinical follow-up studies are sample based, in contrast to arthroplasty register data, which refer to the entire population treated. Aim of this study is to assess the differences in revision rate to quantify bias-factors in published literature.
Materials and Methods: A structured literature review of Medline-listed peer reviewed journals concerning the STAR Total Ankle Replacement have been conducted.
The published results from clinical follow up studies have been compared to Arthroplasty register Results: Results: 24% of all papers were published by the inventor of the implant.
These publications show a 3,4 times lower revision rate compared to independent studies and a 4,6 times lower revision rate compared to Register based publications.
The cumulative revision rate per 100 observed component years of register based publications is 1,36 times higher compared to independent clinical studies. The difference is statistically not significant.
Pooling the published data from all follow up studies the impact of the studies published by the inventor leads to a statistically significant bias.
Discussion and Conclusion: Publications by the inventor of the implant are overrepresented in peer reviewed scientific journals. This bias has a statistically significant impact on the final result of a Metaanalyses.
Arthroplasty Register data are able to detect bias factors and lead to a better quality of assessments concerning the outcome of arthroplasty.
Correspondence should be addressed to: EFORT Central Office, Technoparkstrasse 1, CH – 8005 Zürich, Switzerland. Email: office@efort.org
