NCT00545285

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis of Hip
• Traumatic Arthritis of Hip

Interventions

Type	Name	Description
PROCEDURE	Total Hip Arthroplasty	Surgical implantation of specific hip replacement components for treatment of osteoarthritis

Timeline

• Start date: 2007-11-01
• Primary completion: 2023-05-01
• Completion: 2023-05-01
• First posted: 2007-10-17
• Last updated: 2017-05-03

Locations

1 site across 1 country: United States