Actively Recruiting
Clinical Performance of XPEO-E Liner in SERF Dual-mobility Cups for Total Hip Arthroplasty
Led by Societe dEtude, de Recherche et de Fabrication · Updated on 2026-04-13
500
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical performance of the XPEO-E liner used in SERF dual-mobility cups for total hip arthroplasty (THA). This observational study aims to collect data to support transitioning the XPEO-E liner to meet the new Medical Device Regulation (MDR 2017/745) in the EU. The XPEO-E liner has CE marking under the Medical Device Directive by equivalency with the CI E liner, but no direct data on its performance is yet available. The XPEO-E liner is intended for use with NOVAE cups, SERF femoral heads, and stems as part of hip replacement surgery to improve quality of life and reduce pain caused by damaged joints. The devices will be used according to their CE markings. Follow-up visits will follow current medical practice, with additional data collected through questionnaires completed by patients and surgeons. Participants will be followed for up to 5 years after surgery. Researchers will assess functional improvement, survival rate of the implant, pain relief, quality of life, patient satisfaction, and any adverse events. The study collects information during standard operative and post-operative periods, using questionnaires and clinical evaluations to monitor outcomes and safety over time.
CONDITIONS
Brief 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 who needs to be implanted 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 such as guardianship or curatorship
- Patient unable to express consent
- Patient deprived of liberty or hospitalized without consent
- Pregnant or breastfeeding patient
- Patient with contraindications to medical device implantation per instructions for use
- Patient with contraindications to radiographic follow-up
- Patient unlikely to follow scheduled visits
- Patient unable to complete self-questionnaires
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Per operative period
Participants undergo implantation of the SERF total hip prosthesis and receive immediate post-operative care.
1 surgical visit and immediate post-operative visits
Duration - Up to 5 years
Participants are followed for up to 5 years to assess functional improvement, pain relief, quality of life, satisfaction, survival rate, and adverse events related to the implant.
Regular follow-up visits over 5 years
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
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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