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

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.

NCT Number	NCT06917365
Lead Sponsor	Societe dEtude, de Recherche et de Fabrication
Conditions	Total Hip Arthroplasty (THA)
Enrollment	500 participants
Start Date	2025-10-27
Primary Completion	2032-03-31 (estimated)
Study Completion	2032-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-04-13