NCT00535626

Trident® Tritanium™ Acetabular Shell Revision Study

A Post-market, Non-randomized, Open Label, Multi-center Clinical Study of the Trident Tritanium Acetabular Shell

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 241 (actual)
• Sponsor: Stryker Orthopaedics · Industry
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate a hip implant system used when a previous hip replacement surgery has failed.

Detailed description

Total hip replacement is considered to be a very successful surgical procedure for the treatment of degenerative joint disease. Clinical results for cementless acetabular components have demonstrated excellent long-term fixation of these devices. However, so called 'first generation' cementless acetabular components have not had similar success rates. In these cases the acetabular component is often revised due to loosening, wear or infection. Revision hip arthroplasty also becomes a challenge as patients often present with severe bone loss and poor bone quality. This can lead to compromised initial stability, which in turn leads to lack of long-term fixation and failure. Acetabular revision with a cementless component has shown improved results over cemented fixation. Radiographic evaluation of the Trident® Tritanium™ Acetabular Shell will provide valuable early to intermediate information that may help predict the long-term success of this new system. It is the intention of this study to closely follow subjects that have undergone revision hip replacement with regard to implant survivorship, signs of radiographic loosening, subjects' function evaluated through Harris Hip Score and Lower Extremity Activity Scale, subject quality of life through SF-36 and adverse events. The primary efficacy hypothesis is that the rate of revision or pending revision (as defined by radiographic parameters) due to instability or lack of fixation for the Trident® Tritanium™ Acetabular Shell will be less than 10% at 5 years.

Conditions

• Arthroplasty, Replacement, Hip

Interventions

Type	Name	Description
DEVICE	Trident® Tritanium™ Acetabular Shell	Trident® Tritanium™ Acetabular Shell

Timeline

• Start date: 2006-11-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2007-09-26
• Last updated: 2017-11-20
• Results posted: 2017-11-20

Locations

15 sites across 1 country: United States