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

Societe dEtude, de Recherche et de Fabrication42 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hip Arthropathy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Outcomes

Primary Outcomes

Survival Rate at Mid Term Follow-up

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.

Time frame: Between 4 to 7 years after surgery

Secondary Outcomes

Adverse Events

List type and frequency of complications, investigated by clinical and radiological examination following investigator's usual practice

Time frame: From per operative period to 4/6 years after surgery

Survival Rates at Mid Term Follow-up (by Component)

Assess the survival rates at least, 4 year-follow-up, whatever the cause of revision, regarding each component of the prothesis