Actively Recruiting
Clinical Performance of XPEO-E Liner in SERF Dual-mobility Cups
Led by Societe dEtude, de Recherche et de Fabrication · Updated on 2026-04-13
500
Participants Needed
5
Research Sites
335 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Clinical Performance of XPEO-E Liner in SERF Dual-mobility Cups
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female adults
- Patient needing implantation with a SERF total hip prosthesis
- Patient meeting Instructions for Use (IFU) requirements
- Patient affiliated to French social security
- Patient who has provided a dated and signed informed consent form
You will not qualify if you...
- Patient under French legal protection measures (guardianship or curatorship)
- Patient unable to express consent
- Patient deprived of liberty or hospitalized against consent
- Pregnant or breastfeeding patient
- Patient with contraindication to medical device implantation per instructions for use
- Patient with contraindication to radiographic follow-up
- Patient unlikely to comply with follow-up visit schedule
- Patient unable to complete self-questionnaires
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
CHU Dijon
Dijon, France
Actively Recruiting
2
HCL Croix-Rousse
Lyon, France
Actively Recruiting
3
HCL Lyon Sud
Lyon, France
Not Yet Recruiting
4
CHU Saint Etienne
Saint-Etienne, France
Actively Recruiting
5
CHU Strasbourg
Strasbourg, France
Actively Recruiting
Research Team
C
Clinical department
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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