XPEO-E liner with SERF dual-mobility hip cups for total hip replacement
Clinical Performance of XPEO-E Liner in SERF Dual-mobility Cups
This project will test how well the XPEO-E hip liner performs and is tolerated in adults receiving a SERF total hip replacement.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Societe dEtude, de Recherche et de Fabrication Industry-sponsored |
| Locations | 5 sites (Dijon and 4 other locations) |
| Trial ID | NCT06917365 on ClinicalTrials.gov |
What this trial studies
This is an observational post-market data collection of the XPEO-E polyethylene liner used with NOVAE cups and SERF femoral heads and stems in routine total hip arthroplasty. Participants receive the devices according to their CE marking and usual surgical practice, and follow-up visits follow standard clinical care. Additional data are collected via patient- and surgeon-completed questionnaires to capture function, pain, and device performance. The goal is to gather device-specific clinical data to support regulatory transition to MDR 2017/745 in the EU.
Who should consider this trial
Good fit: Adults who require implantation with a SERF total hip prosthesis, meet the device instructions for use, can give informed consent, and are affiliated with French social security are ideal candidates.
Not a fit: Patients with legal protection, inability to consent, pregnancy or breastfeeding, contraindications to implantation or radiographic follow-up, inability to complete questionnaires, or who cannot comply with follow-up are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the data could support wider regulatory approval and give patients confidence in the liner's safety and performance after hip replacement.
How similar studies have performed: Dual-mobility cup designs and polyethylene liners have prior favorable clinical experience, but no published clinical data specific to the XPEO-E liner are available, making this device-specific collection novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female adults. * Patient that needs to be implanted with a SERF total hip prosthesis. * Patient responding to IFU requirement. * Patient affiliated to French social security. * Patient who has provided a dated and signed informed consent form. Exclusion Criteria: * Patient protected by a French legal measure (under legal protection, guardianship or curatorship). * Patient unable of expressing consent, according to the investigator. * Patient deprived of liberty or hospitalized against his consent. * Pregnant or breastfeeding patient. * Patient presenting a contraindication to the implantation of medical devices according to the instructions for use. * Patient with a contraindication to radiographic follow-up. * Patient not being, a priori, capable of respecting the schedule of follow-up visits, according to the investigator. * Patient unable to complete a self-questionnaire, according to the investigator.
Where this trial is running
Dijon and 4 other locations
- CHU Dijon — Dijon, France (Recruiting)
- HCL Croix-Rousse — Lyon, France (Recruiting)
- HCL Lyon Sud — Lyon, France (Not_yet_recruiting)
- CHU Saint Etienne — Saint-Etienne, France (Recruiting)
- CHU Strasbourg — Strasbourg, France (Recruiting)
Study contacts
- Study coordinator: Clinical department
- Email: clinical@serf.fr
- Phone: +33472056010
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.