Long-term evaluation of hip prostheses performance
Hip Prospective Study: Long-term Post-market Clinical Follow-up on the Use of SERF Hip Prostheses
Societe dEtude, de Recherche et de Fabrication · NCT05956236
This study is trying to see how well certain hip implants work and how safe they are for adults getting these devices over a 15-year period.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Societe dEtude, de Recherche et de Fabrication (industry) |
| Locations | 1 site (Saint-Priest-en-Jarez) |
| Trial ID | NCT05956236 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather long-term clinical data on hip prostheses as part of the Post-Market Clinical Follow-up (PMCF) process mandated by European regulations. It will involve a multicentric, prospective investigation over a 15-year period, focusing on the safety, performance, and benefits of these devices in real-life settings. Participants will be adults who are scheduled to receive specific hip implants from the manufacturer SERF, following an observation period of alternative treatments. The study is designed to ensure compliance with health authority requirements and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 60-65 and older with severe hip pain or disability who have not sufficiently improved with other treatments.
Not a fit: Patients who are pregnant, breastfeeding, or unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of hip prostheses, leading to improved patient care.
How similar studies have performed: Other studies have shown the importance of long-term data collection for medical devices, indicating that this approach is both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Saint-Priest-en-Jarez
- CHU St Etienne — Saint-Priest-en-Jarez, France (RECRUITING)
Study contacts
- Study coordinator: Clinical department
- Email: clinical@serf.fr
- Phone: 0472056010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hip Arthropathy, Hip arthropalsty, Hip Prosthesis