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Ambispective Study to Assess the Safety and the Performance of SAGITTA EVL R Stem — 2022-09  

Hip Arthropathy Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06096155
Study type Observational
Source Societe dEtude, de Recherche et de Fabrication
Contact Lydie BONNEVAY
Phone 04 72 05 60 10
Email l.bonnevay@serf.fr
Status Recruiting
Phase
Start date June 13, 2023
Completion date August 31, 2024
View Details
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