Triathlon Tritanium Cone Augments Outcomes Study

Running, not enrolling · Not applicable

Conditions studied: Arthroplasty, Replacement, Knee

In brief

The purpose of this study was to evaluate the success rate of the Triathlon Tritanium Cone Augment with the Triathlon TS Total Knee System at 2 years postoperative, defined as absence of revision of the Femoral Cone Augment or Tibial Cone augment for aseptic loosening.

Key facts

Study ID

NCT02521103

Run by

Stryker Orthopaedics

People needed

254

Starts

2015-08-01

Expected to finish

2028-03-31

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Orlando Health — Zephyrhills, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Bluegrass Orthopaedics — Lexington, Kentucky, United States
• The CORE Institute — Novi, Michigan, United States
• Michigan Heart, St. Joseph Health System — Ypsilanti, Michigan, United States
• Missouri Orthopaedic Institute — Columbia, Missouri, United States
• Rothman Institute — Egg Harbor, New Jersey, United States
• The Orthopaedic Center — Tulsa, Oklahoma, United States
• Providence Medical Research Center — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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