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

Not Applicable

• Conditions: Total Hip Replacement
• Interventions: Other: radio stereometric analysis (RSA) of the acetabular; Device: standard polyethylene acetabular irradiated at 3 Mrad; Device: acetabular polyethylene vitamys®

• Registration Number: NCT02524587
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2015-08-06
• Study First Submitted QC: 2015-08-13
• Study First Posted: 2015-08-17
• Primary Completion: 2016-11
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-10
• Last Update Posted: 2018-09-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acetabular polyethylene vitamys®	radio stereometric analysis (RSA) of the acetabular	acetabular polyethylene vitamys®
standard polyethylene acetabular irradiated at 3 Mrad	radio stereometric analysis (RSA) of the acetabular	standard polyethylene acetabular irradiated at 3 Mrad
standard polyethylene acetabular irradiated at 3 Mrad	standard polyethylene acetabular irradiated at 3 Mrad	standard polyethylene acetabular irradiated at 3 Mrad
acetabular polyethylene vitamys®	acetabular polyethylene vitamys®	acetabular polyethylene vitamys®

Primary Outcome Measures

Name	Time	Method
penetration of the metal femoral head in acetabular	2 years	head penetration in milimeters

Trial Locations

Locations (1)

Département d'orthopédie - traumatologie, CHU de Caen; 🇫🇷 Caen, France