Tritanium® Primary Acetabular Shell Study

Stopped early · Not applicable

Conditions studied: Arthroplasty, Replacement, Hip

In brief

This study will be a prospective, non-randomized evaluation of the Tritanium® Acetabular Shell for primary total hip replacement (THR) with a cementless application in a consecutive series of patients who meet the eligibility criteria. Half of the cases will use the Trident® X3® polyethylene insert alone as the bearing surface; the other half will use the modular dual mobility (MDM™) liner coupled with a compatible anatomic dual mobility (ADM™)/MDM™ X3® insert as the bearing surface. The success rate, defined as freedom from acetabular revision for any reason, for hips implanted with the Tritanium® Acetabular Shell, is no worse than for hips implanted with similar technology as reported in the literature and Trident® X3® Study historical control at 5 years postoperative.

Key facts

Study ID

NCT01063751

Run by

Stryker Orthopaedics

People needed

275

Starts

2011-07-01

Expected to finish

2023-12-30

Last updated by the study team

2025-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A. Patient has signed an IRB approved, study specific Informed Patient Consent Form.
• B. Patient is a male or non-pregnant female age 18 years or older at time of study device implantation.
• C. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
• 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 and rehabilitation.

You may not qualify if…

• F. Patient has a Body Mass Index (BMI) ≥ 40.
• G. Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
• H. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
• I. 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.
• J. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
• K. Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint.
• L. Patient has a known sensitivity to device materials.
• M. Patient is a prisoner.

Where it is running

• Adventist Health St. Helena — St. Helena, California, United States
• Florida Medical Clinic — Tampa, Florida, United States
• University of Kentucky Research Foundation — Lexington, Kentucky, United States
• Center for Orthopaedics and Spine, LLP — Lake Charles, Louisiana, United States
• Northern Light Eastern Maine Medical Center — Bangor, Maine, United States
• Syracuse Orthopedic Specialists, P.C. — Syracuse, New York, United States
• West Virginia University — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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