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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hip Arthropathy

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate at mid term follow-up | Assess the survival rate at least, 4 year-follow-up, whatever the cause of revision | At 4/6 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | List type and occurence of adverse events, investigated by clinical and radiological examination following investigator's usual practice | 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 | At 4/6 years after surgery | 
| Survival rates at mid term follow-up (by etiology) | Assess the survival rates at least, 4 year-follow-up, whatever the cause of revision, regarding etiology | At 4/6 years after surgery | 
| Patient's satisfaction | Assessed by the surgeon through questionary with a 5 item-scale : very satisfied / satisfied / neither satisfied - nor unsatisfied / unsatisfied / very unsatisfied | At 4/6 years after surgery | 
| Oblivion of prosthesis | Assess the degree of forgetfulness of the prosthesis using FJS-score (Forgotten Joint Score) : FJS stands for Forgotten Joint Score. The Forgotten Joint Score assessment consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities | At 4/6 years after surgery | 
| Functional improvement | Evaluate pain, walking, limping and activities of daily life using Harris Hip Score : The global Harris Hip Score consists of a 0 to 100 points scale (100 points is the better outcome) | At 4/6 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Hip Prosthesis Revision