NCT06096155

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 61 (estimated)
• Sponsor: Societe dEtude, de Recherche et de Fabrication · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hip Arthropathy

Timeline

• Start date: 2023-06-13
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2023-10-23
• Last updated: 2024-03-04

Locations

1 site across 1 country: France