NCT04618770

Triathlon PSR Outcomes Study

A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon Total Knee System Using the Triathlon PSR Tibial Insert

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Stryker Orthopaedics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Triathlon Total Knee System using the Triathlon PSR Tibial Insert for primary total knee arthroplasty (TKA) in a consecutive series of patients who meet the eligibility criteria. The SF-36 score of subjects receiving the Triathlon Total Knee with the Triathlon PSR insert is expected to be comparable with that of subjects receiving historical Triathlon PS cemented constructs.

Conditions

• Arthroplasty
• Knee

Interventions

Type	Name	Description
DEVICE	Triathlon PSR Tibial Insert	The Triathlon PSR Tibial Insert is intended to be used as a component in primary TKA and is designed to reduce rotational constraint at deep flexion.

Timeline

• Start date: 2021-02-08
• Primary completion: 2023-01-27
• Completion: 2023-01-27
• First posted: 2020-11-06
• Last updated: 2023-12-11
• Results posted: 2023-11-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study