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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2022-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparative Study of the Wear of Uncemented Acetabular Conventional Polyethylene and X3 in Total Hip Replacement, for Stereo-radiographic Analysis

NCT02525770

Total Hip Arthroplasty

UNKNOWN NA

Incidence of Dual Mobility Polyethylene Wear in Total Hip Prosthesis. Randomised Study Versus Fixed Insert by Radiostereometric Analysis.

NCT02525809

Total Hip Replacement

COMPLETED NA

Polyethylene Wear Particle Analysis of THA

NCT06432543

Wear of Articular Bearing Surface of Prosthetic Joint Hip Arthropathy

RECRUITING

Migration and Head Penetration of Vitamin-E Diffused Cemented Polyethylene Cup in Total Hip Arthroplasty

NCT02254980

Total Hip Arthroplasty

ACTIVE_NOT_RECRUITING NA

Vitamin E Polyethylene in Semented Cups

NCT04126421

Total Hip Arthroplasty (THA)

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Total Hip Replacement

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

acetabular polyethylene vitamys®

Group Type ACTIVE_COMPARATOR

radio stereometric analysis (RSA) of the acetabular

Intervention Type OTHER

acetabular polyethylene vitamys®

Intervention Type DEVICE

standard polyethylene acetabular irradiated at 3 Mrad

Group Type ACTIVE_COMPARATOR

standard polyethylene acetabular irradiated at 3 Mrad

Intervention Type DEVICE

radio stereometric analysis (RSA) of the acetabular

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

standard polyethylene acetabular irradiated at 3 Mrad

Intervention Type DEVICE

radio stereometric analysis (RSA) of the acetabular

Intervention Type OTHER

acetabular polyethylene vitamys®

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No