Trident II Tritanium Acetabular Shell Outcomes Study



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - 80
Updated:2/20/2019
Start Date:January 20, 2017
End Date:February 2029
Contact:Alice Cruz
Email:alice.cruz@stryker.com
Phone:201-831-5859

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

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.


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.
We found this trial at
7
sites
Tucson, Arizona 85713
Principal Investigator: Russell Cohen, MD
Phone: 520-784-6146
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Chapel Hill, North Carolina 27599
Principal Investigator: Daniel Del Gaizo, MD
Phone: 919-966-5495
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Chapel Hill, NC
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Egg Harbor Township, New Jersey 08234
Principal Investigator: Fabio Orozco, MD
Phone: 609-677-7015
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Egg Harbor Township, NJ
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Jacksonville, Florida 32204
Principal Investigator: Max Lincoln, MD
Phone: 904-634-0640
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Jacksonville, FL
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535 East 70th Street
New York, New York 10021
Principal Investigator: Geoffrey Westrich, MD
Phone: 212-606-1510
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New York, NY
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Westmont, Illinois 60559
Principal Investigator: Benjamin Domb, MD
Phone: 630-920-2323
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Westmont, IL
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5301 McAuley Drive
Ypsilanti, Michigan 48197
Principal Investigator: Michael Masini, MD
Phone: 734-712-8087
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Ypsilanti, MI
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