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Trident II Tritanium Acetabular Shell Outcomes Study | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

Trident II Tritanium Acetabular Shell Outcomes Study

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

NCT02999009•Stryker Orthopaedics

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

Locations (9)

Tucson Orthopaedic Institute

Tucson, Arizona, United States

Southeast Orthopedic Specialists

Jacksonville, Florida, United States

American Hip Institute

Des Plaines, Illinois, United States

Center for Orthopaedics and Spine, LLC

Lake Charles, Louisiana, United States

St. Joseph Mercy Hospital Health System

Ypsilanti, Michigan, United States

Rothman Institute

Egg Harbor, New Jersey, United States

Hospital for Special Surgery

New York, New York, United States

Northwell Health, Lenox Hill Hospital

New York, New York, United States

UNC Orthopaedics

Chapel Hill, North Carolina, United States

Key Dates

Start Date

January 20, 2017

Primary Completion Date

March 1, 2026

Completion Date

March 1, 2031

Last Updated

November 24, 2025

Enrollment

383

ACTUAL participants

Conditions

Arthroplasty, Replacement, Hip

Interventions

Trident II Tritanium Acetabular Shell

DEVICE

Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.

NCT05169229

Arthroplasty, Replacement, HipOsteoarthritis, Hip+2 more

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RECRUITINGNA

Low Concentration Local Anesthesia Fascia Iliaca Block for Total Hip Arthroplasty

NCT06102811

Arthroplasty, Replacement, Hip

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Trident II Tritanium Acetabular Shell Outcomes Study

Inclusion Criteria

Exclusion Criteria

Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.

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