Trident® X3 Polyethylene Insert Study

Arthroplasty, Replacement, Hip Clinical Trial

Official title: An Open-label, Prospective, Post-market, Historically Controlled, Multi-center Clinical Evaluation of the Trident® X3 Polyethylene Acetabular Inserts.

Status Completed

Clinical Trial Summary

The primary objective of the study is to demonstrate the linear wear rates of the Trident® X3 polyethylene insert are superior to a polyethylene control group wear rate at 5 years postoperative. This measurement will be evaluated by comparing digitized images of serial radiographs obtained over a follow-up period of 5-years.

Clinical Trial Description

The study is a prospective, multi-center, historical-controlled clinical evaluation of the Trident® X3 Polyethylene insert. The device is commercially available in the United States where the study is being conducted. The study device, the Stryker Orthopaedics Trident® X3 polyethylene insert, is used for the replacement of the bearing surface of the acetabulum to relieve pain, instability, and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, trauma, or failure of other devices. The control device, the Stryker Orthopaedics N2VAC polyethylene insert, is also used for the replacement of the bearing surface of the acetabulum to relieve pain, instability, and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, trauma, or failure of other devices. ;

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip

• NCT number: NCT00958191
• Study type: Interventional
• Source: Stryker Orthopaedics
• Status: Completed
• Phase: N/A
• Start date: May 2005
• Completion date: December 2016