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New knee implant aims to reduce repeat surgeries

NCT ID NCT02521103

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at a device called the Triathlon Tritanium Cone Augment, used in revision knee replacement surgery. Researchers want to see if it helps prevent the need for further surgery due to loosening. About 254 people who need a full knee replacement revision are being followed for 2 years to check how well the device holds up.

What this could mean

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

Active substance
Triathlon Tritanium Cone Augments (a medical device used in knee revision surgery)
What this could lead to
If successful, this device could provide a more durable option for people needing revision knee replacement, reducing the chance of needing another surgery due to loosening.
What could go wrong
This is a post-market study, not a randomized trial, so results may not apply to all patients. The device may still fail or cause pain, and long-term outcomes beyond 2 years are not yet known.

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

254 people

The number who actually took part.

Start date

Aug 2015

Expected to finish

Mar 2028

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.

Inclusion Criteria: * Patient has signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved, study specific Informed Patient Consent Form. * Patient is a male or non-pregnant female, skeletally mature and age 18 years or older at time of study device implantation. * Patient is a candidate for revision of all femoral and tibial components of a total knee replacement. * Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation. Exclusion Criteria: * Patient has a Body Mass Index (BMI) \> 45. * Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation. * Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device. * Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration. * Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days). * Patient has a failed unicondylar knee prosthesis. * Patient has a known sensitivity to device materials. * Patient is a prisoner.

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As listed by the trial registrant

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

Arthroplasty KNEE Replacement

Contacts and locations

Locations

  • Bluegrass Orthopaedics

    Lexington, Kentucky, 40509, United States

  • Michigan Heart, St. Joseph Health System

    Ypsilanti, Michigan, 48197, United States

  • Missouri Orthopaedic Institute

    Columbia, Missouri, 65212, United States

  • Orlando Health

    Zephyrhills, Florida, 33542, United States

  • Providence Medical Research Center

    Spokane, Washington, 99208, United States

  • Rothman Institute

    Egg Harbor, New Jersey, 08234, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • The CORE Institute

    Novi, Michigan, 48374, United States

  • The Orthopaedic Center

    Tulsa, Oklahoma, 74104, United States

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