Status:
TERMINATED
Trident II Revision Outcomes Study
Lead Sponsor:
Stryker Orthopaedics
Conditions:
Arthroplasty, Hip Revision
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 27 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04317586
Start Date
June 23 2020
End Date
January 27 2023
Last Update
December 1 2023
Active Locations (10)
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1
Lafayette General Orthopedic Center
Lafayette, Louisiana, United States, 70506
2
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
University of Massachusetts
Worcester, Massachusetts, United States, 01605