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Knee device under review: will it stand the test of time?

NCT ID NCT04636190

Disease control Sponsor: Stryker Orthopaedics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how well a specific knee replacement device, the Triathlon All-Polyethylene Tibia, works in people with knee arthritis. Researchers will follow 204 patients who already have the device to see how their knee function and pain change over time. The goal is to check the device's long-term performance and survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Triathlon All-Polyethylene Tibia knee device
What this could lead to
If successful, this study could confirm that this knee replacement device provides good long-term function and durability for patients with knee arthritis.
What could go wrong
This is an observational study, not a randomized trial, so results may be less definitive. The device is already on the market, so this is a post-market check, not a breakthrough.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

204 people

The number who actually took part.

Started

Jul 2021

Expected to finish

Oct 2033

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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.

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 duration of treatment). * Patient is a prisoner.

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Conditions

The condition(s) this trial relates to.

osteoarthritis, knee

As listed by the trial registrant

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

Arthropathy of knee Knee arthritis Replacement

Contacts and locations

Locations

  • Department of Orthopaedic Surgery Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Duke University Medical Center

    Durham, North Carolina, 27703, United States

  • Kaleida Health, Department of Orthopaedic Surgery, Buffalo General Hospital

    Buffalo, New York, 14203, United States

  • Michigan Orthopaedic Center

    Lansing, Michigan, 48910, United States

  • Musculoskeletal Institute, University of Texas Health Austin

    Austin, Texas, 78712, United States

  • Syracuse Orthopedic Specialists, PC

    Syracuse, New York, 13214, United States

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