Hip Prospective Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hip Arthropathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Hip Prospective Study: Long-term Post-market Clinical Follow-up on the Use of SERF Hip Prostheses
Overview
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.
Primary outcome measures
- Survival rate [Time frame: Per operative period to 15 years]
Secondary outcome measures (11)
- Intermediate survival rates [Time frame: Per operative period to 10 years]
- Functional improvement [Time frame: Per operative period to 15 years]
- Functional improvement [Time frame: Per operative period to 15 years]
- Functional improvement [Time frame: Per operative period to 15 years]
- Functional improvement [Time frame: Per operative period to 15 years]
- Leg length discrepancy [Time frame: Pre operative period to 15 years]
- Patient's Pain [Time frame: Pre operative period to 15 years]
- Patient's quality of life [Time frame: Pre operative period to 15 years]
- Patient's satisfaction [Time frame: Post operative period to 15 years]
- Surgeon's satisfaction [Time frame: Per operative period to 15 years]
- Adverse events [Time frame: Per operative period to 15 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- CHU St Etienne — Saint-Priest-en-Jarez
Identifiers
NCT: NCT05956236 · HiPS