Study of the Wear of a Highly Cross-linked Polyethylene Acetabular Doped With Vitamin E and Coated With Titanium in Total Hip Replacement
Overview
- Phase
- Not Applicable
- Sponsor
- University Hospital, Caen
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- penetration of the metal femoral head in acetabular
Overview
Brief Summary
The total hip replacement, with over 120,000 cases per year in France, provides short term, excellent functional results and a significant improvement in quality of life, in almost all cases. However, the observation has shown that the lifetime of the implants is limited due to aseptic loosening. One of the factors associated with these failures is a peri-prosthetic osteolysis wherein the polyethylene wear debris (PE) have been implicated. Several solutions have been proposed: change the friction torque (hard-hard pairs using ceramic or metal on the two components of the couple) or improving quality polyethylene. Improving the resistance of polyethylene wear is the primary objective evaluated in this study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients aged men and women 18 to 75 years
- •with a primary or secondary osteoarthritis or osteonecrosis
- •having a functional disorder requiring the installation of a total hip prosthesis of primary
Exclusion Criteria
- •patients aged 76 years or more
- •pregnant or desiring to be for the duration of the study
- •minors or adults protected
- •repeated hip replacement
- •cephalic prosthesis recovery or intermediate
- •repeated cupules
- •primary or secondary malignant tumor of the hip
Outcomes
Primary Outcomes
penetration of the metal femoral head in acetabular
Time Frame: 2 years
head penetration in milimeters
Secondary Outcomes
No secondary outcomes reported