At a glance
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Ambispective Study Evaluating the Clinical Results of SAGITTA EVL R Revision Stems
In Brief
An observational study for Hip Arthropathy. Completed, enrolled 42 participants across 1 site.
Detailed Summary
This clinical study is conducted to collect data on hip arthroplasty with the SAGITTA EVL-R revision femoral stems manufactured by SERF. In order to reflect current practice, a comprehensive and continuous series of patients will be included. This study will confirm the performance and safety of the SAGITTA EVL R revision femoral stems within the framework of MDR 2017/745 and in relation to the recommendations of the MEDDEV guide 2.7.1. Rev 4 (Clinical Evaluation Guide), which provides for a systematic procedure to monitor clinical data in order to verify the claimed performance of medical devices.