NCT06379321 Evaluation of Outcomes of the Triathlon Hinge Knee (THK) System
| NCT ID | NCT06379321 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Cleveland Clinic |
| Condition | Knee Arthropathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-05-10 |
| Primary Completion | 2034-05-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-05-10 with a primary completion date of 2034-05-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Nicolas Piuzzi, MD
PRINCIPAL INVESTIGATOR
Associate Staff Orthopaedic Surgery
Frequently Asked Questions
Who can join the NCT06379321 clinical trial?
This trial is open to participants of all sexes, studying Knee Arthropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06379321 currently recruiting?
Yes, NCT06379321 is actively recruiting participants. Contact the research team at stiegel@ccf.org for enrollment information.
Where is the NCT06379321 trial being conducted?
This trial is being conducted at Weston, United States, Cleveland, United States.
Who is sponsoring the NCT06379321 clinical trial?
NCT06379321 is sponsored by The Cleveland Clinic. The principal investigator is Nicolas Piuzzi, MD at Associate Staff Orthopaedic Surgery. The trial plans to enroll 200 participants.