Trident II Tritanium Acetabular Shell Outcomes Study

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Arthroplasty, Replacement, Hip
• Intervention / Treatment: Device: Trident II Tritanium Acetabular Shell

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.

• Study Type: Interventional
• Enrollment (Actual): 383
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Tucson Orthopaedic Institute
  • Florida
    • Jacksonville, Florida, United States, 32204
      • Southeast Orthopedic Specialists
  • Illinois
    • Des Plaines, Illinois, United States, 60018
      • American Hip Institute
  • Louisiana
    • Lake Charles, Louisiana, United States, 70605
      • Center for Orthopaedics and Spine, LLC
  • Michigan
    • Ypsilanti, Michigan, United States, 48197
      • St. Joseph Mercy Hospital Health System
  • New Jersey
    • Egg Harbor, New Jersey, United States, 08234
      • Rothman Institute
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery
    • New York, New York, United States, 10075
      • Northwell Health, Lenox Hill Hospital
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Orthopaedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

A. Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form.

B. Patient is a male or non-pregnant female age 18-80 years of age at the time of study device implantation.

C. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease.

D. Patient is a candidate for a primary cementless total hip replacement.

E. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.

Exclusion Criteria:

F. Patient has a Body Mass Index (BMI) ≥ 40.

G. Patient is diagnosed with Inflammatory Arthritis.

H. Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.

I. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.

J. Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.

K. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).

L. Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint.

M. Patient has had previous open surgery to the affected joint, not including arthroscopy.

N. Patient requires implantation of a constrained liner.

O. Patient has a known sensitivity to device materials.

P. Patient is a prisoner.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Trident II Tritanium Acetabular Shell; The Trident II Tritanium Acetabular Shell is a hemispherical acetabular shell intended for use in a cementless application.	Device: Trident II Tritanium Acetabular Shell; A hemispherical acetabular shell indicated for cementless application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absence of Revision for the Trident II Tritanium Acetabular Shell	To demonstrate that acetabular replacement with the Trident II Tritanium Acetabular Shell provides clinical results comparable to similar acetabular components.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause Revision and Removal Rates for the Trident II Tritanium Acetabular Shell	Survivorship percentage (one reported value) for both all-cause revision + removal will be indicated	10 years
Radiographic Stability	Numerous parameters will be reviewed by zone, including radiolucency and migration.	6 weeks, 3-6 months, 1, 2, 5, 7, 10 years

Collaborators and Investigators

• Sponsor: Stryker Orthopaedics
• Investigators: Study Director: Kevin Barga, Director, Clinical Research - Stryker Joint Replacement

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2017
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): March 1, 2031

Study Registration Dates

• First Submitted: December 12, 2016
• First Submitted That Met QC Criteria: December 16, 2016
• First Posted (Estimated): December 21, 2016

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 78

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes