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Knee replacement system under Long-Term review

NCT ID NCT06379321

Knowledge-focused Sponsor: The Cleveland Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how well the Triathlon Hinge Knee System works in people who need knee replacement surgery, either for the first time or to fix a previous one. Researchers will follow about 200 patients for up to 10 years to see how long the implant lasts and how well patients function. The goal is to gather information, not to test a new treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

May 2034

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants who meet the eligibility criteria and receive/received devices from the Triathlon Hinge Knee System according to its indications for use (IFU).

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

arthropathy bacterial arthritis infective arthritis Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Knee arthropathy Knee infection Recurrence

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Cleveland Clinic Florida

    RECRUITING

    Weston, Florida, 33331, United States

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