NCT02524587

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	standard polyethylene acetabular irradiated at 3 Mrad
OTHER	radio stereometric analysis (RSA) of the acetabular
DEVICE	acetabular polyethylene vitamys®

Timeline

• Start date: 2010-01-01
• Primary completion: 2016-11-01
• Completion: 2022-11-01
• First posted: 2015-08-17
• Last updated: 2018-09-11

Locations

1 site across 1 country: France