Hip Prospective Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Survival rate [Per operative period to 15 years]
To assess the survival rate of the investigational medical devices at the end of their claimed implantation duration
Secondary Outcome Measures
- Intermediate survival rates [Per operative period to 10 years]
To assess the survival rate of the investigational medical devices at the intermediate timepoints
- Functional improvement [Per operative period to 15 years]
To assess the evolution of patient's functional capacity post-implantation using HOOS score
- Functional improvement [Per operative period to 15 years]
To assess the evolution of patient's functional capacity post-implantation using Harris Hips score
- Functional improvement [Per operative period to 15 years]
To assess the evolution of patient's activity post-implantation using UCLA scale
- Functional improvement [Per operative period to 15 years]
To assess the evolution of patient's activity post-implantation using Charnley score
- Leg length discrepancy [Pre operative period to 15 years]
To assess patient's leg length discrepancy post-implantation (visual evaluation)
- Patient's Pain [Pre operative period to 15 years]
To assess patient's pain (Visual Analogic Scale)
- Patient's quality of life [Pre operative period to 15 years]
To assess patient's quality of life post-implantation (Forgotten Joint Score)
- Patient's satisfaction [Post operative period to 15 years]
To assess patients' satisfaction with the operation (4-points question)
- Surgeon's satisfaction [Per operative period to 15 years]
To assess surgeons' satisfaction with the operation
- Adverse events [Per operative period to 15 years]
To assess the long-term safety of investigational medical devices as well as post-operative safety of the surgery
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female adults
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Planned to be implanted with investigational medical devices per the IFUs:
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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
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Implantation of investigational medical devices as integrated systems (all components from SERF, no component from another manufacturer)
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For an intended purpose and indication listed in the IFUs
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Affiliated to French social security
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Who provided a dated and signed informed consent form
Exclusion Criteria:
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Patient protected by a French legal measure
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Patient not able to express his/her consent as deemed by the investigator
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Patient deprived of liberty or hospitalized without consent
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Pregnant or breastfeeding women
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Patient contraindicated to investigational medical devices implantation per the IFUs
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Patient contraindicated to radiographic follow-up
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Patient a priori not able to meet the follow-up visits as deemed by the investigator
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Patient not able to fulfil a self-assessment questionnaire as deemed by the investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU St Etienne | Saint-Priest-en-Jarez | France | 42270 |
Sponsors and Collaborators
- Societe dEtude, de Recherche et de Fabrication
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HiPS