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Evaluation of Outcomes of the Triathlon Hinge Knee (THK) System
A Retrospective/Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon Hinge Knee (THK) System
Who can join
All ages · All sexes
Full eligibility criteria
Inclusion Criteria: * The subject undergoes a primary or revision procedure implanting at least the Revision Baseplate portion of the Triathlon Hinge Knee System in accordance with the Indications for Use. * The subject has signed an Institutional Review Board (IRB)/Ethical Committee (EC)-approved, study-specific Informed Consent Form (ICF). * The subject is a male or non-pregnant female at the time of enrollment. * The subject agrees to comply with the protocol-mandated clinical evaluations. Exclusion Criteria: * Any active or suspected latent infection in or about the knee joint; overt infection; * Distant foci of infection which may cause hematogenous spread to the implant site; rapid disease progression as manifested by joint destruction or bone resorption apparent on roentgenogram; * skeletally immature patients; * Severe instability of the knee joint secondary to the absence of collateral ligament integrity and function. * Bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis. * Known or suspected sensitivity and/or allergy to any material in the device. * Conditions presenting an increased risk of failure include: * uncooperative patient or patient with neurologic disorder, incapable of following instructions; * osteoporosis; * metabolic disorders which may impair bone formation or cause bone loss; * osteomalacia; and, * previous arthrodesis. * A higher incidence of implant failure has also occurred in paraplegics, cerebral palsy and patients with Parkinson's disease. * Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care. * The subject is a prisoner
About the study
This study is a prospectively and retrospectively enrolled, post-market, open-label, non-randomized, single institution evaluation of clinical outcomes of primary or revision knee surgery patients who meet the eligibility criteria and received devices from the Triathlon Hinge Knee System according to its indications for use (IFU).
Clinical evaluation for all cases will include data collection of patient demographics, surgical details, early postoperative status, functional and clinical outcomes, and survivorship at 1, 2, 6, and 10-years.
What is being tested
- Triathlon Hinge Knee (THK) System (device)
Sponsor: The Cleveland Clinic · Participants: 200 · Started: May 10, 2024
Contact the study team
- Laura Stiegel · Phone: 216-442-5511
- Sanal Krishnan, PHD · Phone: 216-445-7194
Official record on ClinicalTrials.gov — NCT06379321
Locations in the U.S.
| Florida | Cleveland Clinic Florida, Weston |
| Ohio | Cleveland Clinic, Cleveland |
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.