Hip Prospective Study

Study Overview
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Brief Summary
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In an evaluation report dated 2014, the HAS (Haute Autorité de Santé -French National Authority for Health) highlights that long-term clinical data on hip prostheses are needed in the context of the French healthcare system. In addition, per the European Regulation 2017/745, medical devices manufacturers shall conduct Post-Market Clinical Follow-up (PMCF) on their devices or provide a justification why PMCF is not applicable. Therefore, as part of the PMCF process of their hip prostheses, SERF wants to conduct a PMCF investigation to ensure the long-term real-life performance, safety and benefits of these prostheses. HiPS is a non-comparative, prospective, multicentric, national, 15-year follow-up clinical investigation.

Official Title
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Hip Prospective Study: Long-term Post-market Clinical Follow-up on the Use of SERF Hip Prostheses

Conditions
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Hip Arthropathy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female adults Planned to be implanted with investigational medical devices per the IFUs: Implantation in skeletally mature adults (usually aged 60-65 and over), with an extremely painful and/or disabled joint and insufficiently improved by alternative treatment options after an observation period lasting from a few weeks to a few months Implantation of investigational medical devices as integrated systems (all components from SERF, no component from another manufacturer) For an intended purpose and indication listed in the IFUs Affiliated to French social security Who provided a dated and signed informed consent form Exclusion Criteria: Patient protected by a French legal measure Patient not able to express his/her consent as deemed by the investigator Patient deprived of liberty or hospitalized without consent Pregnant or breastfeeding women Patient contraindicated to investigational medical devices implantation per the IFUs Patient contraindicated to radiographic follow-up Patient a priori not able to meet the follow-up visits as deemed by the investigator Patient not able to fulfil a self-assessment questionnaire as deemed by the investigator.

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 | To assess the survival rate of the investigational medical devices at the end of their claimed implantation duration | Per operative period to 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intermediate survival rates | To assess the survival rate of the investigational medical devices at the intermediate timepoints | Per operative period to 10 years | 
| Functional improvement | To assess the evolution of patient's functional capacity post-implantation using HOOS score | Per operative period to 15 years | 
| Functional improvement | To assess the evolution of patient's functional capacity post-implantation using Harris Hips score | Per operative period to 15 years | 
| Functional improvement | To assess the evolution of patient's activity post-implantation using UCLA scale | Per operative period to 15 years | 
| Functional improvement | To assess the evolution of patient's activity post-implantation using Charnley score | Per operative period to 15 years | 
| Leg length discrepancy | To assess patient's leg length discrepancy post-implantation (visual evaluation) | Pre operative period to 15 years | 
| Patient's Pain | To assess patient's pain (Visual Analogic Scale) | Pre operative period to 15 years | 
| Patient's quality of life | To assess patient's quality of life post-implantation (Forgotten Joint Score) | Pre operative period to 15 years | 
| Patient's satisfaction | To assess patients' satisfaction with the operation (4-points question) | Post operative period to 15 years | 
| Surgeon's satisfaction | To assess surgeons' satisfaction with the operation | Per operative period to 15 years | 
| Adverse events | To assess the long-term safety of investigational medical devices as well as post-operative safety of the surgery | Per operative period to 15 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip arthropalsty, Hip Prosthesis