Trials / Recruiting
RecruitingNCT06917365
Clinical Performance of XPEO-E Liner in SERF Dual-mobility Cups
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (estimated)
- Sponsor
- Societe dEtude, de Recherche et de Fabrication · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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.
Conditions
Timeline
- Start date
- 2025-10-27
- Primary completion
- 2032-03-31
- Completion
- 2032-03-31
- First posted
- 2025-04-08
- Last updated
- 2026-04-13
Locations
5 sites across 1 country: France
Source: ClinicalTrials.gov record NCT06917365. Inclusion in this directory is not an endorsement.