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

Study Research and Manufacturing Company (SERF)

Status: Enrolling

Conditions: Hip Arthropathy

Study type: Observational

Funder types: Industry

Identifiers

NCT06096155

2022-09_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.

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.

Enrollment: 61 estimated 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 01/01/2010 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.