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Active, not recruiting Not applicable

Triathlon All-Polyethylene Tibia Outcomes Study

NCT04636190 · tracked via the Priya Life Science USA tracker
Phase
Not applicable
Started
2021-07-02
Last updated
2026-02-27

Condition(s) studied

Arthropathy of KneeReplacementKnee Arthritis

Investigational drug(s) / intervention(s)

Triathlon All-Polyethylene Tibia Knee

Triathlon All-Polyethylene Tibia Knee: Triathlon All-Polyethylene Tibia Knee is an all polyethylene resurfacing knee device using either a condylar stabilizing (CS) and posterior stabilizing (PS) device.

Study summary

The purpose of this study is to evaluate the clinical functional results of the Triathlon All-Polyethylene Tibia Knee Device.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Knee Society Score (KSS) Function — 10-years postoperative
    The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome postoperative.

Trial sites (6)

FacilityCityRegionStatus
Michigan Orthopaedic Center Lansing Michigan
Kaleida Health, Department of Orthopaedic Surgery, Buffalo General Hospital Buffalo New York
Syracuse Orthopedic Specialists, PC Syracuse New York
Duke University Medical Center Durham North Carolina
Department of Orthopaedic Surgery Cleveland Clinic Cleveland Ohio
Musculoskeletal Institute, University of Texas Health Austin Austin Texas

More Stryker Orthopaedics trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04636190 on ClinicalTrials.gov ↗ ← All trials in the USA