Actively Recruiting
Interest of a Highly Cross-linked Polyethylene Acetabular Component Doped With Vitamin E in Total Hip Arthroplasty of the Young and Active Subject
Led by GCS Ramsay Santé pour l'Enseignement et la Recherche · Updated on 2025-12-03
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates the use of a highly cross-linked polyethylene acetabular component doped with vitamin E in total hip arthroplasty for young and active adults aged 18 to 65 years with hip arthropathy. The study compares this new type of prosthesis to a ceramic-on-ceramic prosthesis to understand their performance and benefits in hip replacement surgery. Participants are randomly assigned to one of two groups: one group receives a prosthesis with a second-generation ceramic-on-highly cross-linked polyethylene (CoPXE) couple, while the other group receives a prosthesis with ceramic-on-ceramic (CoC) torque. The study is single-blind and conducted at a single center. During the study, researchers will measure the wear thickness of the two friction pairs over five years to assess durability. Participants will undergo regular follow-up visits for monitoring, including evaluations related to the prosthesis and hip function. The total participation period includes these assessments and monitoring visits to ensure safety and gather outcome data.
CONDITIONS
Brief Title
Interest of a Highly Cross-linked Polyethylene Acetabular Component Doped With Vitamin E in Total Hip Arthroplasty of the Young and Active Subject
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged 18 to 65 years
- Signed consent to participate in the study
- Indication for total hip arthroplasty has been given
You will not qualify if you...
- History of hip surgery
- Indication for a dual mobility prosthesis (obese patient, dynamic spino-pelvic anomaly)
- Hip dysplasia
- Inflammatory rheumatic disease or any progressive condition affecting vital or functional prognosis
- Sequelae of neurological disease or stroke
- Pregnant or breastfeeding women
- Mental deficiency or other reason hindering understanding or protocol adherence
- Likely not to return for follow-up visits
- Already included in another therapeutic study protocol
- Under court protection, guardianship, or curatorship
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 - 1 day
Participants receive a total hip arthroplasty with either a ceramic-on-highly cross-linked polyethylene (CoPXE) prosthesis or a ceramic-on-ceramic (CoC) prosthesis.
1 surgical visit
Duration - Up to 5 years
Participants are followed for outcomes including wear thickness of the prosthesis over five years.
Periodic visits during follow-up
Trial Site Locations
Total: 1 location
1
Hôpital Privé Jean Mermoz
Lyon, France, 69008
Actively Recruiting
Research Team
J
Jean LANGLOIS, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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