NCT06917365 Clinical Performance of XPEO-E Liner in SERF Dual-mobility Cups
| NCT ID | NCT06917365 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Societe dEtude, de Recherche et de Fabrication |
| Condition | Total Hip Arthroplasty (THA) |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-10-27 |
| Primary Completion | 2032-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2025-10-27 with a primary completion date of 2032-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
XPEO-E liner is CE marked under MDD 93/42/CEE by equivalency with CI E liner. No pertaining data on XPEO-E liner is yet available. However, clinical evaluation concludes on a reaching of performance and safety and compliance with essential requirements. This study intends to collect data on XPEO-E in order to allow a transit to MDR 2017/745 (EU). XPEO-E liner is intended to be used with NOVAE cups and SERF femoral heads and Stems. XPEO-E liner will be used according to their CE marking. These devices are intended for hip replacements with the aim of improving quality of life and reducing pain by replacing a damaged joint. The follow-up visits are established according to the current practice. Additional procedure will only consist on questionnaires that will be filled by the patient and/or the surgeons.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06917365 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Total Hip Arthroplasty (THA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06917365 currently recruiting?
Yes, NCT06917365 is actively recruiting participants. Contact the research team at clinical@serf.fr for enrollment information.
Where is the NCT06917365 trial being conducted?
This trial is being conducted at Dijon, France, Lyon, France, Lyon, France, Saint-Etienne, France and 1 additional location.
Who is sponsoring the NCT06917365 clinical trial?
NCT06917365 is sponsored by Societe dEtude, de Recherche et de Fabrication. The trial plans to enroll 500 participants.