NCT00958191

Trident® X3 Polyethylene Insert Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Stryker Orthopaedics · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Arthroplasty, Replacement, Hip

Interventions

Type	Name	Description
DEVICE	Trident® X3 Polyethylene Insert	Trident® X3 Polyethylene Insert

Timeline

• Start date: 2005-05-01
• Primary completion: 2012-07-01
• Completion: 2016-12-01
• First posted: 2009-08-13
• Last updated: 2018-02-23
• Results posted: 2014-07-14

Locations

9 sites across 1 country: United States