Triathlon All-Polyethylene Tibia Outcomes Study

NCT04636190 | Active Not Recruiting FDA Device

• 1 other identifier: 104
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Arthropathy of Knee; Replacement; Knee Arthritis

Outcome Measures

Primary Outcomes (1)

• Knee Society Score (KSS) Function

  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.

  10-years postoperative

Secondary Outcomes (1)

• Kaplan-Meier Survival Analysis

  10-years postoperative

Study Arms (1)

Triathlon All-Polyethylene Tibia Knee

OTHER

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

Device: Triathlon All-Polyethylene Tibia Knee

Interventions

Triathlon All-Polyethylene Tibia Knee DEVICE

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

Triathlon All-Polyethylene Tibia Knee

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Study Sites (6)

Michigan Orthopaedic Center

Lansing, Michigan, 48910, United States

Location

Kaleida Health, Department of Orthopaedic Surgery, Buffalo General Hospital

Buffalo, New York, 14203, United States

Location

Syracuse Orthopedic Specialists, PC

Syracuse, New York, 13214, United States

Location

Duke University Medical Center

Durham, North Carolina, 27703, United States

Location

Department of Orthopaedic Surgery Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Musculoskeletal Institute, University of Texas Health Austin

Austin, Texas, 78712, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 19, 2020
• Study Start: July 2, 2021
• Primary Completion (Estimated): October 1, 2033
• Study Completion (Estimated): October 1, 2033
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (6)