NCT06096168

Ambispective Study Evaluating the Clinical Results of SAGITTA EVL R Revision Stems

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 42 (actual)
• 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. 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.

Conditions

• Hip Arthropathy

Timeline

• Start date: 2023-04-13
• Primary completion: 2024-10-29
• Completion: 2024-10-29
• First posted: 2023-10-23
• Last updated: 2025-06-25
• Results posted: 2025-06-25

Locations

1 site across 1 country: France