NCT00960206

ABC/Trident® Ceramic Post Approval Study

Post-Approval Study of the ABC and Trident® Systems

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 413 (actual)
• Sponsor: Stryker Orthopaedics · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Arthroplasty, Replacement, Hip

Interventions

Type	Name	Description
DEVICE	Trident® Ceramic Insert/Trident® AD HA Acetabular Shell	Trident® Ceramic Insert/Trident® AD HA Acetabular Shell
DEVICE	Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell	Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell
DEVICE	OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell	OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell

Timeline

• Start date: 2003-03-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2009-08-17
• Last updated: 2017-02-03
• Results posted: 2014-08-15

Locations

6 sites across 1 country: United States