Trident II Revision Outcomes Study

Stopped early · Not applicable

Conditions studied: Arthroplasty, Hip Revision

In brief

The purpose of this study is to review the performance and success rate of an FDA cleared 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

NCT04317586

Run by

Stryker Orthopaedics

People needed

17

Starts

2020-06-23

Expected to finish

2023-01-27

Last updated by the study team

2023-12-01

Who can join

Age: 18 and older, up to 85. 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 18-85 years of age at the time of study device implantation.
• C. Patient is a candidate for a revision of a failed acetabular component with a cementless acetabular component.
• D. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.

You may not qualify if…

• E. Patient has a Body Mass Index (BMI) > 45. F. Patient is diagnosed with Inflammatory Arthritis. G. Patient has a non-Stryker retained stem. 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 mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
• J. Patient has compromised bone stock which cannot provide adequate support and/or fixation to the prosthesis.
• K. 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.
• L. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days). M. Patient has a known sensitivity to device materials. N. Patient is a prisoner.

Where it is running

• Lafayette General Orthopedic Center — Lafayette, Louisiana, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Massachusetts — Worcester, Massachusetts, United States
• Beaumont Hospital Research Institute — Royal Oak, Michigan, United States
• The Orthopaedic & Fracture Clinic, P.A. — Mankato, Minnesota, United States
• Reno Orthopedic Center Foundation — Reno, Nevada, United States
• OrthoNY — Albany, New York, United States
• Syracuse Orthopedic Specialists — New York, New York, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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