Clinical Research Directory

Ambispective Study to Assess the Safety and the Performance of SAGITTA EVL R Stem

Sponsor: Societe dEtude, de Recherche et de Fabrication

Summary

This clinical study is conducted to collect data on hip arthroplasty with the SAGITTA EVL-R revision femoral stems manufactured by SERF. 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. The primary objective is to evaluate the long-term survival rate (7 to 10 years post-op +/- 2 years) of SAGITTA EVL R stems. Secondary objectives are to : * study long term patient satisfaction with their hip prosthesis, * confirm the long-term safety of these implants by studying the possible complications observed, * evaluate the performance of these implants using clinical scores.

Key Details

Conditions

Locations (1)