ABC/Trident® Ceramic Post Approval Study

Status Completed

Clinical Trial Summary

The purpose of the Post Approval Study of the ABC and Trident® systems is to continue to demonstrate the safety and efficacy of the alumina-on-alumina bearing surfaces combined with the appropriate shell in a cementless application.

Clinical Trial Description

The ABC/ Trident® study was initiated in 1996 as an FDA IDE pre-market study in the United States for alumina bearing THR. PreMarket Approval (PMA)application was approved in February 3,2003. The Post Approval Study (PAS) involved six surgeon investigators from the original IDE study. Subjects who consented to participate in the Post Approval Study continued to be followed to collect limited patient reported data regarding status of the hip. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Arthroplasty, Replacement, Hip

Clinical Trial Details

NCT number	NCT00960206
Study type	Interventional
Source	Stryker Orthopaedics
Contact
Status	Completed
Phase	N/A
Start date	March 2003
Completion date	October 2010

View Details

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