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Completed NCT06096155

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

Conditions: Hip Arthropathy

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 46
Sponsor: Societe dEtude, de Recherche et de Fabrication

Location: Centre Hospitalier Loire Vendée Océan Challans Vendée

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.

Eligibility Criteria

Inclusion Criteria: * Patient over 18 years old at the time of surgery, * Patient implanted with a SAGITTA EVL R revision femoral stem within its indications between 01/01/2010 and 31/12/2015, * Affiliated to French health insurance system Exclusion Criteria: * Patient who has rejected to the use of his/her personal data, * Patient unable to understand the surgeon's instructions or to carry out the post-operative follow-up.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06096155). StuddyBuddy aggregates publicly available trial information.