Triathlon All-Polyethylene Tibia Outcomes Study

NCT ID: NCT04636190

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-02
• Study Completion Date: 2033-10-31

Brief Summary

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

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.

Conditions

Arthropathy of Knee; Replacement; Knee Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Triathlon All-Polyethylene Tibia Knee

All subjects enrolled will have received the Triathlon All-Polyethylene Tibia Knee device.

Group Type: OTHER

Triathlon All-Polyethylene Tibia Knee

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Orthopaedics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Michigan Orthopaedic Center

Lansing, Michigan, United States

Kaleida Health, Department of Orthopaedic Surgery, Buffalo General Hospital

Buffalo, New York, United States

Syracuse Orthopedic Specialists, PC

Syracuse, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Department of Orthopaedic Surgery Cleveland Clinic

Cleveland, Ohio, United States

Musculoskeletal Institute, University of Texas Health Austin

Austin, Texas, United States

Countries

United States

Other Identifiers

104

Identifier Type: -

Identifier Source: org_study_id