Triathlon All-Polyethylene Tibia Outcomes Study

Not Applicable

Recruiting

• Conditions: Replacement; Arthropathy of Knee; Knee Arthritis
• Interventions: Device: Triathlon All-Polyethylene Tibia Knee

• Registration Number: NCT04636190
• Lead 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.

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 Timeline

• Study First Submitted: 2020-11-13
• Study First Submitted QC: 2020-11-13
• Study First Posted: 2020-11-19
• Study Start: 2021-07-02
• Status Verified: 2025-03
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-08
• Primary Completion: 2033-10
• Study Completion: 2033-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Knee Society Score (KSS) Function	10-years postoperative	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.

Secondary Outcome Measures

Name	Time	Method
Kaplan-Meier Survival Analysis	10-years postoperative	To present 10-year Kaplan-Meier survival analysis for the Triathlon APT

Trial Locations

Locations (6)

Michigan Orthopaedic Center; 🇺🇸 Lansing, Michigan, United States

Syracuse Orthopedic Specialists, PC; 🇺🇸 Syracuse, New York, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Kaleida Health, Department of Orthopaedic Surgery, Buffalo General Hospital; 🇺🇸 Buffalo, New York, United States

Department of Orthopaedic Surgery Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Musculoskeletal Institute, University of Texas Health Austin; 🇺🇸 Austin, Texas, United States