Phase
Condition
N/ATreatment
Trident II Tritanium Acetabular Shell for Revision
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 studydevice implantation. C. Patient is a candidate for a revision of a failed acetabular component with a cementlessacetabular component. D. Patient is willing and able to comply with postoperative scheduled clinical andradiographic evaluations.
Exclusion
Exclusion Criteria:
E. Patient has a Body Mass Index (BMI) > 45. F. Patient is diagnosed with InflammatoryArthritis. G. Patient has a non-Stryker retained stem. H. Patient has an active orsuspected latent infection in or about the affected hip joint at time of study deviceimplantation. I. Patient has a mental or neuromuscular disorder which would create an unacceptable riskof prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
J. Patient has compromised bone stock which cannot provide adequate support and/or fixationto the prosthesis.
K. Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolicdisorder (e.g. Paget's Disease) leading to progressive bone deterioration. L. Patient is immunologically suppressed or receiving steroids in excess of normalphysiological requirements (e.g. > 30 days). M. Patient has a known sensitivity to devicematerials. N. Patient is a prisoner.
Study Design
Connect with a study center
Southeast Orthopedic Specialists
Jacksonville, Florida 32204
United StatesSite Not Available
Lafayette General Orthopedic Center
Lafayette, Louisiana 70506
United StatesSite Not Available
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
University of Massachusetts
Worcester, Massachusetts 01605
United StatesSite Not Available
Beaumont Hospital Research Institute
Royal Oak, Michigan 48073
United StatesSite Not Available
The Orthopaedic & Fracture Clinic, P.A.
Mankato, Minnesota 56001
United StatesSite Not Available
Reno Orthopedic Center Foundation
Reno, Nevada 89503
United StatesSite Not Available
OrthoNY
Albany, New York 12205
United StatesSite Not Available
Syracuse Orthopedic Specialists
New York, New York 13214
United StatesSite Not Available
University of Utah
Salt Lake City, Utah 84108
United StatesSite Not Available

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