NCT02999009

Trident II Tritanium Acetabular Shell Outcomes Study

A Prospective, Post-market, Multi-center Study of the Trident II Tritanium Acetabular Shell

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 383 (actual)
• Sponsor: Stryker Orthopaedics · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to review the performance and success rate of an FDA approved cementless hip replacement part called the Trident II Tritanium Acetabular Shell. The study will specifically look at the need to revise the hip replacement after 5 years. This will be compared to how much this happens in patients who have hip replacement with similar cementless acetabular shells.

Detailed description

This study is a prospective, open-label, post-market, non-randomized evaluation of the Trident II Tritanium Acetabular Shell for primary total hip arthroplasty (THA) with a cementless application in a consecutive series of patients who meet the eligibility criteria.

Conditions

• Arthroplasty, Replacement, Hip

Interventions

Type	Name	Description
DEVICE	Trident II Tritanium Acetabular Shell	A hemispherical acetabular shell indicated for cementless application.

Timeline

• Start date: 2017-01-20
• Primary completion: 2026-06-01
• Completion: 2031-03-01
• First posted: 2016-12-21
• Last updated: 2026-04-01

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study