Trident II Tritanium Acetabular Shell Outcomes Study

Running, not enrolling · Not applicable

Conditions studied: Arthroplasty, Replacement, Hip

In brief

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.

Key facts

Study ID

NCT02999009

Run by

Stryker Orthopaedics

People needed

383

Starts

2017-01-20

Expected to finish

2031-03-01

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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