Ambispective Study Evaluating the Clinical Results of SAGITTA EVL R Revision Stems
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hip Arthropathy
- Sponsor
- Societe dEtude, de Recherche et de Fabrication
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Survival Rate at Mid Term Follow-up
- Status
- Completed
- Last Updated
- 10 months ago
Overview
Brief 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.
Investigators
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 01/01/2016 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
Outcomes
Primary Outcomes
Survival Rate at Mid Term Follow-up
Time Frame: Between 4 to 7 years after surgery
Assess the survival rate, at least 4 year-follow-up, whatever the cause of revision. Cumulative survival rate expressed in percentage of implants not revised (remaining in place) using Kaplan Meier calculation.
Secondary Outcomes
- Adverse Events(From per operative period to 4/6 years after surgery)
- Survival Rates at Mid Term Follow-up (by Component)(At 4/6 years after surgery)
- Survival Rates at Mid Term Follow-up (by Etiology)(At 4/6 years after surgery)
- Patient's Satisfaction(At 4/6 years after surgery)
- Oblivion of Prosthesis(At 4/6 years after surgery)
- Functional Improvement(At 4/6 years after surgery)