Clinical trial NCT05956236: Hip Prospective Study
Official title: Hip Prospective Study: Long-term Post-market Clinical Follow-up on the Use of SERF Hip Prostheses
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hip Arthropathy
Keywords: Hip arthropalsty
Hip Prosthesis
Lead sponsor: Societe dEtude, de Recherche et de Fabrication
Sponsor class: INDUSTRY
First posted: 2023-07-21
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients corresponding to the target treated population of the investigational medical devices, planned to be implanted with investigational medical devices per the Instructions for Use (IFU), who can participate to a clinical investigation, are not vulnerable and can meet the follow-up visits (a priori) and fulfil a self-assessment questionnaire will be included.

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.


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.

Primary outcomes:
measure: Survival rate
timeFrame: Per operative period to 15 years
Secondary outcomes:
measure: Intermediate survival rates
timeFrame: Per operative period to 10 years
measure: Functional improvement
timeFrame: Per operative period to 15 years
measure: Functional improvement
timeFrame: Per operative period to 15 years
measure: Functional improvement
timeFrame: Per operative period to 15 years
measure: Functional improvement
timeFrame: Per operative period to 15 years
measure: Leg length discrepancy
timeFrame: Pre operative period to 15 years
measure: Patient's Pain
timeFrame: Pre operative period to 15 years
measure: Patient's quality of life
timeFrame: Pre operative period to 15 years
measure: Patient's satisfaction
timeFrame: Post operative period to 15 years
measure: Surgeon's satisfaction
timeFrame: Per operative period to 15 years
measure: Adverse events
timeFrame: Per operative period to 15 years
Other outcomes:
Locations:
city: Saint-Priest-en-Jarez
country: France
facility: CHU St Etienne
Study officials:
References: