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Clinical Trials in the USA / NCT02999009
Active, not recruiting Not applicable

Trident II Tritanium Acetabular Shell Outcomes Study

NCT02999009 · tracked via the Priya Life Science USA tracker
Sponsor
Stryker Orthopaedics
Phase
Not applicable
Started
2017-01-20
Last updated
2026-06-29

Condition(s) studied

Arthroplasty, Replacement, Hip

Investigational drug(s) / intervention(s)

Trident II Tritanium Acetabular Shell

Trident II Tritanium Acetabular Shell: A hemispherical acetabular shell indicated for cementless application.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
Tucson Orthopaedic Institute Tucson Arizona
Southeast Orthopedic Specialists Jacksonville Florida
American Hip Institute Des Plaines Illinois
Center for Orthopaedics and Spine, LLC Lake Charles Louisiana
St. Joseph Mercy Hospital Health System Ypsilanti Michigan
Rothman Institute Egg Harbor New Jersey
Hospital for Special Surgery New York New York
Northwell Health, Lenox Hill Hospital New York New York
UNC Orthopaedics Chapel Hill North Carolina

More Stryker Orthopaedics trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02999009 on ClinicalTrials.gov ↗ ← All trials in the USA