Hip Arthropathy
Conditions
Keywords
Hip arthropalsty, Hip Prosthesis
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.
Interventions
None listed
Sponsors
Societe dEtude, de Recherche et de Fabrication
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
France
Contacts
CONTACTClinical department
Outcome results
None listed