Ambispective Study Evaluating the Clinical Results of SAGITTA EVL R Revision Stems (2022-10)

Study Research and Manufacturing Company (SERF)

Status: Completed

Conditions: Hip Arthropathy

Study type: Observational

Funder types: Industry

Identifiers

NCT06096168

2022-10_Sagitta EVL-R

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 01/01/2016 and 31/12/2018,
• Affiliated to French health insurance system

Exclusion criteria

• Patient who has not expressed consent for data collection and participation in the study,
• Patient unable to understand the surgeon's instructions or to perform postoperative follow-up.
• Patient with a contraindication to the use of the SAGITTA EVL R revision femoral stem
• Patient implanted with a SAGITTA EVL R revision femoral stem outside its indication

Trial design