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Evaluation of the Triathlon Hinge Knee (THK) System

This study is looking at how well the Triathlon Hinge Knee (THK) System works for people having knee surgery. This system is a type of knee replacement device. The study wants to see how long the device lasts (survivorship) and what might cause it to fail over 1, 2, 6, and 10 years. You could join if you are having primary or revision (repeat) knee surgery and will receive at least part of the Triathlon Hinge Knee System. The study is currently unclear on its recruitment status.

Study design
This is an observational study, meaning researchers will collect information from people who receive the Triathlon Hinge Knee System during their surgery. It is open-label, so everyone will know they are receiving the device, and aims to include 200 participants.
What's involved
You would need to sign an informed consent form. The study will collect information about your demographics, surgery details, early recovery, and how your knee functions at 1, 2, 6, and 10 years after surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 1, 2, 6, and 10 years after their surgery to assess the device's survivorship and clinical outcomes.

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NCT06379321

Evaluation of Outcomes of the Triathlon Hinge Knee (THK) System

Recruiting
Not specifiedAll AgesObservational
The Cleveland Clinic
~200 participants
Updated 2026-03-02 on ClinicalTrials.gov
What's tested:Triathlon Hinge Knee (THK) System

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Survivorship
Measured over 1, 2, 6 and 10 years

Conditions

Knee Arthropathy
Recurrence
Knee Infection

Explore related trials

PyelonephritisTotal Knee Replacement

Where it's being run

2 sites across 2 states
Florida1
Ohio1

Study leadership

  • Nicolas Piuzzi, MD · PRINCIPAL_INVESTIGATOR · Associate Staff Orthopaedic Surgery

Who to contact

Laura Stiegel
[email protected]
216-442-5511
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Survivorship1, 2, 6 and 10 years

    To evaluate the survivorship of the Hinge Knee System at postoperatively. Survival is defined as the absence of aseptic revision to the implanted device.