NCT04636190

Triathlon All-Polyethylene Tibia Outcomes Study

A Retrospectively Enrolled and Prospectively Followed, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon All-Polyethylene Tibia

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Stryker Orthopaedics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2021-07-02
• Primary completion: 2033-10-01
• Completion: 2033-10-01
• First posted: 2020-11-19
• Last updated: 2026-02-27

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study