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Long-Term Multi-center Evaluation of E-Poly and Regenerex

Osteoarthritis of Hip Clinical Trial

Official title:
Long-Term Multi-center Evaluation of E-Poly and Regenerex Cementless Acetabular Components: Clinical and Radiographic Outcomes

Clinical Trial Summary

There are two distinct aims of this study:

1. This prospective study is designed to document the long-term (10-year) radiographic and clinical outcomes of a new type of highly cross-linked polyethylene liner which contains vitamin E as an anti-oxidant, (E-Poly), in a group of primary total hip arthroplasty subjects. The clinical outcome of E-Poly will be compared to a group of subjects receiving Arcom XL polyethylene.

2. This study is also designed to document the long-term (10-year) radiographic and clinical outcomes of a new cementless acetabular component having a titanium porous surface (Regenerex). The clinical outcome of this new FDA cleared device will be compared a group of subjects receiving an acetabular component having a plasma sprayed surface.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00545285
Study type Interventional
Source Massachusetts General Hospital
Contact
Status Active, not recruiting
Phase N/A
Start date November 2007
Completion date May 2023
View Details
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