RecruitingNot Applicable

Clinical Performance of XPEO-E Liner in SERF Dual-mobility Cups

France500 participantsStarted 2025-10-27

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Functional improvement

Timeframe: Per operative period to 5 years

Trial details

NCT IDNCT06917365

SponsorSociete dEtude, de Recherche et de Fabrication

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2032-03-31

Contact for this trial

Clinical department

+33472056010 clinical@serf.fr