Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00208494
Status:
COMPLETED
Last Update Posted:
2013-08-14
First Post:
2005-09-13
Brief Title:
Metal on Metal Versus Ceramic on Metal Hip Replacement
Sponsor:
DePuy Orthopaedics
Organization:
DePuy Orthopaedics
Study Overview
Official Title:
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
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None