Hip Prospective Study
ConditionHip Arthropathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSociete dEtude, de Recherche et de Fabrication
About this trial
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
This trial does not accept healthy volunteersQualifiers
Male or female adults
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Survival rate
To assess the survival rate of the investigational medical devices at the end of their claimed implantation duration
Time frame
Per operative period to 15 yearsSecondary outcomes
1
Intermediate survival rates
To assess the survival rate of the investigational medical devices at the intermediate timepoints
Time frame
Per operative period to 10 years2
Functional improvement
To assess the evolution of patient's functional capacity post-implantation using HOOS score
Time frame
Per operative period to 15 years3
Functional improvement
To assess the evolution of patient's functional capacity post-implantation using Harris Hips score
Time frame
Per operative period to 15 years4
Functional improvement
To assess the evolution of patient's activity post-implantation using UCLA scale
Time frame
Per operative period to 15 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov