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

Total Hip Replacement Clinical Trial

— POLYTITAN  

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02524587
• Other study ID #: 09-113
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2010
• Est. completion date: November 2022

Study information

• Verified date: September 2018
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 62
• Est. completion date: November 2022
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Total Hip Replacement

Intervention

Device:
• standard polyethylene acetabular irradiated at 3 Mrad

Other:
• radio stereometric analysis (RSA) of the acetabular

Device:
• acetabular polyethylene vitamys®

Locations

Country	Name	City	State
France	Département d'orthopédie - traumatologie, CHU de Caen	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	penetration of the metal femoral head in acetabular	head penetration in milimeters	2 years