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NCT04636190 | RECRUITING | Arthropathy of Knee

Triathlon All-Polyethylene Tibia Outcomes Study
Sponsor:

Stryker Orthopaedics

Brief Summary:

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

Condition or disease

Arthropathy of Knee

Replacement

Knee Arthritis

Intervention/treatment

Triathlon All-Polyethylene Tibia Knee

Phase

NA

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 204 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Retrospectively Enrolled and Prospectively Followed, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon All-Polyethylene Tibia
Actual Study Start Date : 2021-07-02
Estimated Primary Completion Date : 2033-10
Estimated Study Completion Date : 2033-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Triathlon All-Polyethylene Tibia Outcomes Study

Location Details

NCT04636190

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Road cancer

Michigan Orthopaedic Center

Lansing, Road cancer, United States, 48910

RECRUITING

United States, New York

Kaleida Health, Department of Orthopaedic Surgery, Buffalo General Hospital

Buffalo, New York, United States, 14203

RECRUITING

United States, New York

Syracuse Orthopedic Specialists, PC

Syracuse, New York, United States, 13214

TERMINATED

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27703

RECRUITING

United States, Ohio

Department of Orthopaedic Surgery Cleveland Clinic

Cleveland, Ohio, United States, 44195

RECRUITING

United States, Texas

Musculoskeletal Institute, University of Texas Health Austin

Austin, Texas, United States, 78712