Phase
Condition
N/ATreatment
Triathlon All-Polyethylene Tibia Knee
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusions:
Patient underwent primary TKA and is currently implanted with the Triathlon All- Polyethylene Tibia as well as compatible Stryker femoral and patellar components with no pending revision or removal.
Patient has signed an IRB-approved, study specific Informed Patient Consent Form.
Patient is a male or non-pregnant female and is 18 years of age or older at the time of study device implantation.
Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.
Exclusions:
Patient had an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
Patient had distant foci of infection which could have caused hematogenous spread to the implant site at time of study device implantation.
Patient was skeletally immature at time of study device implantation.
Patient has a mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
Patient's bone stock was compromised by disease, infection, or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
Patient had severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.
Patient was immunologically suppressed or receiving steroids in excess of normal physiological requirements at the time of surgery (e.g. > 30 days).
Patient is a prisoner.
Study Design
Study Description
Connect with a study center
Michigan Orthopaedic Center
Lansing, Michigan 48910
United StatesActive - Recruiting
Kaleida Health, Department of Orthopaedic Surgery, Buffalo General Hospital
Buffalo, New York 14203
United StatesActive - Recruiting
Syracuse Orthopedic Specialists, PC
Syracuse, New York 13214
United StatesActive - Recruiting
Duke University Medical Center
Durham, North Carolina 27703
United StatesTerminated
Department of Orthopaedic Surgery Cleveland Clinic
Cleveland, Ohio 44195
United StatesActive - Recruiting
Musculoskeletal Institute, University of Texas Health Austin
Austin, Texas 78712
United StatesActive - Recruiting
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