Actively Recruiting
Hip Prospective Study: Long-term Post-market Clinical Follow-up on the Use of SERF Hip Prostheses
Led by Societe dEtude, de Recherche et de Fabrication · Updated on 2026-04-14
5000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a long-term study to evaluate the real-life performance, safety, and benefits of SERF hip prostheses in adults with hip arthropathy. This investigation responds to the need for extended clinical data on hip prostheses within the French healthcare system and follows European regulations requiring post-market clinical follow-up for medical devices. The study is a prospective, multicenter, national project planned to last 15 years. Participants will be adults scheduled to receive SERF hip prostheses as part of their treatment. The study does not involve comparisons or interventions beyond the standard implant procedure. Instead, it focuses on tracking the long-term outcomes of these devices after implantation, including survival rates and functional improvements over the 15-year period. During participation, individuals will be monitored regularly to assess various outcomes such as the survival rate of the prostheses, patient pain levels, quality of life, satisfaction from both patients and surgeons, and any adverse events. Assessments include evaluations before and after surgery, with follow-up visits planned throughout the 15 years. The study aims to provide comprehensive data on the safety and effectiveness of SERF hip prostheses over time.
CONDITIONS
Brief Title
Hip Prospective Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female adults
- Planned to be implanted with investigational medical devices per the Instructions for Use (IFUs)
- Implantation in skeletally mature adults, usually aged 60-65 and over, with a very painful or disabled joint not improved by other treatments after observation
- Implantation of devices as integrated systems with all components from SERF
- Intended purpose and indication listed in the IFUs
- Affiliated to French social security
- Provided a dated and signed informed consent form
You will not qualify if you...
- Protected by a French legal measure
- Unable to give consent as determined by the investigator
- Deprived of liberty or hospitalized without consent
- Pregnant or breastfeeding women
- Contraindicated to device implantation per the IFUs
- Contraindicated to radiographic follow-up
- Likely unable to attend follow-up visits as judged by the investigator
- Unable to complete self-assessment questionnaires as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Per operative period
Participants receive implantation of SERF hip prostheses and immediate care following surgery.
1 surgical visit and immediate post-operative assessments
Duration - Up to 15 years
Participants are monitored through follow-up visits to assess survival rate, functional improvement, pain, quality of life, satisfaction, leg length discrepancy, and adverse events for up to 15 years after surgery.
Regular follow-up visits over 15 years
Trial Site Locations
Total: 1 location
1
CHU St Etienne
Saint-Priest-en-Jarez, France, 42270
Actively Recruiting
Research Team
C
Clinical department
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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