Pooled outcome of total hip arthroplasty with the CementLess Spotorno (CLS) system: a comparative analysis of clinical studies and worldwide arthroplasty register data
Patrick Sadoghi,corresponding author Wolfgang Janda, Mark Agreiter, Rauend Rauf, Andreas Leithner, and Gerold LabekHip
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.
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