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

NCT02524587 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2018-09-11

No results posted yet for this study

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.

Conditions

  • Total Hip Replacement

Interventions

DEVICE

standard polyethylene acetabular irradiated at 3 Mrad

OTHER

radio stereometric analysis (RSA) of the acetabular

DEVICE

acetabular polyethylene vitamys®

Sponsors & Collaborators

  • University Hospital, Caen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2016-11-30
Completion
2022-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02524587 on ClinicalTrials.gov