Ambispective Study to Assess the Safety and the Performance of SAGITTA EVL R Stem

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. 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.

Official Title
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Ambispective Study to Assess the Safety and the Performance of SAGITTA EVL R Stem

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 01/01/2010 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.

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/long term follow-up | Assess the survival rate at 7/10 year-follow-up, whatever the cause of revision | At 7/10 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 7/10 years after surgery | 
| Adverse events | List type and occurence of adverse events | At 7/10 years after surgery | 
| Oblivion of prosthesis | Assess the degree of forgetfulness of the prosthesis using FJS-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 7/10 years after surgery | 
| Pain release | Evaluate pain using Modified Harris Hip Score : The global Harris Hip Score consists of a 0 to 100 points scale (100 points is the better outcome). The pain evaluation is picked out from the global Harris Hip Score. The pain item is scored on a 0 to 44 points scale (44 points means no pain). | At 7/10 years after surgery | 
| Functional improvement | Evaluate walking, limping and activities of daily life using Modified Harris Hip Score : The global Harris Hip Score consists of a 0 to 100 points scale (100 points is the better outcome). The functional improvement is picked out from the global Harris Hip Score and can be measured with 3 subscores : The walking ablility is assessed by 2 items (support for walk and distance walked, each one is scored a 0 to 11 points scale (11 points is the better outcome). The limping is assessed by a 0 to 11 points scale (11 points is the better outcome). The activities of daily life are assessed by a 0 to 14 points scale (14 points is the better outcome). | At 7/10 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