NCT00208494

Metal on Metal Versus Ceramic on Metal Hip Replacement

Comparative Study to Evaluate the Safety and Efficacy of the DePuy Ceramic-on-metal Total Hip Prosthesis Versus the DePuy Metal-on-metal Total Hip Prosthesis Through Clinical and Radiographical Data

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 392 (actual)
• Sponsor: DePuy Orthopaedics · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the performance of artificial hips with metal heads and metal sockets to artificial hips with ceramic heads articulating with metal socket components. The success of the total hip arthroplasty (THA) will be based upon all of the following clinical and radiographic criteria being met at the two-year evaluation: (1) the patient's clinical results as measured using modified Harris Hip evaluation rating system, and the absence of a complication that requires the surgical removal or replacement of a component; and (2) radiographic findings at study endpoint (i.e., two years follow-up). Clinical and radiographic success at two (2) years postoperative is required for the study hip to be deemed successful.

Detailed description

This study is a prospective, multi-center, randomized, single blind, controlled clinical investigation comparing the safety and efficacy of the cementless Ceramic on Metal total hip prostheses versus the cementless Metal on Metal total hip prostheses.

Conditions

• Non-inflammatory Joint Diseases

Interventions

Type	Name	Description
DEVICE	Total Hip Replacement	Total hip replacement
DEVICE	Total hip replacement	Total hip replacement

Timeline

• Start date: 2005-08-01
• Primary completion: 2008-12-01
• Completion: 2011-06-01
• First posted: 2005-09-21
• Last updated: 2013-08-14
• Results posted: 2011-08-04

Locations

9 sites across 2 countries: United States, Canada