Trident II Tritanium Acetabular Shell Outcomes Study

NCT02999009 | Active Not Recruiting FDA Device

• 1 other identifier: 78
• Study Type: interventional
• Target: 383
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Arthroplasty, Replacement, Hip

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• All-cause Revision and Removal Rates for the Trident II Tritanium Acetabular Shell

  10 years

• Radiographic Stability

  6 weeks, 3-6 months, 1, 2, 5, 7, 10 years

Study Arms (1)

Trident II Tritanium Acetabular Shell

OTHER

The Trident II Tritanium Acetabular Shell is a hemispherical acetabular shell intended for use in a cementless application.

Device: Trident II Tritanium Acetabular Shell

Interventions

Trident II Tritanium Acetabular Shell DEVICE

A hemispherical acetabular shell indicated for cementless application.

Trident II Tritanium Acetabular Shell

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Study Sites (9)

Tucson Orthopaedic Institute

Tucson, Arizona, 85712, United States

Location

Southeast Orthopedic Specialists

Jacksonville, Florida, 32204, United States

Location

American Hip Institute

Des Plaines, Illinois, 60018, United States

Location

Center for Orthopaedics and Spine, LLC

Lake Charles, Louisiana, 70605, United States

Location

St. Joseph Mercy Hospital Health System

Ypsilanti, Michigan, 48197, United States

Location

Rothman Institute

Egg Harbor, New Jersey, 08234, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Northwell Health, Lenox Hill Hospital

New York, New York, 10075, United States

Location

UNC Orthopaedics

Chapel Hill, North Carolina, 27599, United States

Location

Study Officials

• Kevin Barga

  Director, Clinical Research - Stryker Joint Replacement

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: December 21, 2016
• Study Start: January 20, 2017
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): March 1, 2031
• Last Updated: April 1, 2026

Record last verified: 2025-11

Locations

US (9)