Triathlon All-Polyethylene Tibia Outcomes Study

Last updated: May 6, 2025
Sponsor: Stryker Orthopaedics
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Triathlon All-Polyethylene Tibia Knee

Clinical Study ID

NCT04636190
104
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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).

  • Patient is a prisoner.

Study Design

Total Participants: 204
Treatment Group(s): 1
Primary Treatment: Triathlon All-Polyethylene Tibia Knee
Phase:
Study Start date:
July 02, 2021
Estimated Completion Date:
October 31, 2033

Study Description

This study is a retrospectively enrolled, prospective evaluation of the Triathlon All-Polyethylene Tibia (APT) for patients who meet the eligibility criteria. The enrolled cases will be followed for outcomes measured to 10 years. A modular, Triathlon metal-backed tibia (MBT) and polyethylene insert construct will be used as a historical control.

Connect with a study center

  • Michigan Orthopaedic Center

    Lansing, Michigan 48910
    United States

    Active - Recruiting

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

    Buffalo, New York 14203
    United States

    Active - Recruiting

  • Syracuse Orthopedic Specialists, PC

    Syracuse, New York 13214
    United States

    Active - Recruiting

  • Duke University Medical Center

    Durham, North Carolina 27703
    United States

    Terminated

  • Department of Orthopaedic Surgery Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Musculoskeletal Institute, University of Texas Health Austin

    Austin, Texas 78712
    United States

    Active - Recruiting

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