Study of the Wear of a Highly Cross-linked Polyethylene Acetabular Doped With Vitamin E and Coated With Titanium in Total Hip Replacement (POLYTITAN)

Caen University Hospital

Status: Unknown

Conditions: Total Hip Replacement

Treatments: Other: radio stereometric analysis (RSA) of the acetabular; Device: standard polyethylene acetabular irradiated at 3 Mrad; Device: acetabular polyethylene vitamys®

Study type: Interventional

Funder types: Other

Identifiers

NCT02524587

09-113

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

acetabular polyethylene vitamys®

Active Comparator group

Description:

acetabular polyethylene vitamys®

Treatment:

Other: radio stereometric analysis (RSA) of the acetabular

Device: acetabular polyethylene vitamys®

standard polyethylene acetabular irradiated at 3 Mrad

Active Comparator group

Description:

standard polyethylene acetabular irradiated at 3 Mrad

Treatment:

Other: radio stereometric analysis (RSA) of the acetabular

Device: standard polyethylene acetabular irradiated at 3 Mrad