RecruitingNCT06917365

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

Sponsor

Societe dEtude, de Recherche et de Fabrication

Enrollment

500 participants

Start Date

Oct 27, 2025

Study Type

OBSERVATIONAL

Conditions

Total Hip Arthroplasty (THA)

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria8

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.