Total Hip Replacement
Conditions
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.
Interventions
DEVICEstandard polyethylene acetabular irradiated at 3 Mrad
OTHERradio stereometric analysis (RSA) of the acetabular
DEVICEacetabular polyethylene vitamys®
Sponsors
University Hospital, Caen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| penetration of the metal femoral head in acetabular | 2 years | head penetration in milimeters |
Countries
France
Outcome results
None listed