Abstract
Our aim was to elucidate the pooled outcome of the CementLess Spotorno (CLS) system in total hip arthroplasty (THA). We compared the outcome of clinical inventor studies, independent clinical studies, and worldwide register data. The main endpoints for analysis were revision rates. 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). 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.
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