Triathlon Tritanium Knee Outcomes Study

Stopped early · Not applicable

Conditions studied: Arthroplasty, Replacement, Knee

In brief

The success of the Triathlon Tritanium Knee will be determined by comparing the rate of absence of revision for aseptic loosening of the tibial baseplate at 2 years with the rates reported in the literature.

Key facts

Study ID

NCT02155712

Run by

Stryker Orthopaedics

People needed

680

Starts

2014-10-01

Expected to finish

2023-03-11

Last updated by the study team

2023-11-14

Who can join

Age: 18 and older, up to 75. 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 age 18-75 years at time of study device implantation.
• Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
• Patient is a candidate for primary cementless total knee replacement, including a resurfaced patella.
• 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) > 40.
• Patient has a diagnosis of avascular necrosis or inflammatory arthritis.
• 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.
• Subject 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 is diagnosed with lumbar radicular pain.
• Patient has a known sensitivity to device materials.
• Patient is a prisoner.

Where it is running

• OrthoArizona — Gilbert, Arizona, United States
• Tucson Orthopaedic Institute — Tucson, Arizona, United States
• Heekin Clinic — Jacksonville, Florida, United States
• Imperial Health — Lake Charles, Louisiana, United States
• Sinai Hospital of Baltimore — Baltimore, Maryland, United States
• St. Joseph Mercy Health System — Ypsilanti, Michigan, United States
• Rothman Orthopaedic Institute — Egg Harbor, New Jersey, United States
• Mission Hospital Research Institute — Asheville, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Geisinger Orthopaedic Institute — Danville, Pennsylvania, United States

Full record on ClinicalTrials.gov

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