Phase
Condition
N/ATreatment
Trident II Tritanium Acetabular Shell
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
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.
Study Design
Connect with a study center
Tucson Orthopaedic Institute
Tucson, Arizona 85712
United StatesSite Not Available
Southeast Orthopedic Specialists
Jacksonville, Florida 32204
United StatesSite Not Available
American Hip Institute
Des Plaines, Illinois 60018
United StatesSite Not Available
Hinsdale Orthopaedics
Westmont, Illinois 60559
United StatesSite Not Available
Center for Orthopaedics and Spine, LLC
Lake Charles, Louisiana 70605
United StatesSite Not Available
St. Joseph Mercy Hospital Health System
Ypsilanti, Michigan 48197
United StatesSite Not Available
Rothman Institute
Egg Harbor Township, New Jersey 08234
United StatesSite Not Available
Hospital for Special Surgery
New York, New York 10021
United StatesSite Not Available
Northwell Health, Lenox Hill Hospital
New York, New York 10075
United StatesSite Not Available
UNC Orthopaedics
Chapel Hill, North Carolina 27599
United StatesSite Not Available
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