NCT02521103

Triathlon Tritanium Cone Augments Outcomes Study

A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon TS Total Knee System With Triathlon Tritanium Cone Augments

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 145 (estimated)
• Sponsor: Stryker Orthopaedics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Triathlon TS Total Knee System with Triathlon Tritanium Cone Augments for revision total knee arthroplasty (TKA) in a consecutive series of patients who meet the eligibility criteria. The revision rate of the Triathlon Tritanium Cone Augments is expected to be less than 2.8% for aseptic loosening of either the Femoral or the Tibial Cone Augments at 2 years postoperative.

Conditions

• Arthroplasty
• Replacement
• Knee

Interventions

Type	Name	Description
DEVICE	Triathlon Tritanium Cone Augments	The Triathlon Tritanium Cone Augments are an extension of the Triathlon Total Stabilizer (TS) system, intended to be used as an optional accessory component in primary or revision TKA

Timeline

• Start date: 2015-08-01
• Primary completion: 2025-03-31
• Completion: 2028-03-31
• First posted: 2015-08-13
• Last updated: 2025-12-05

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study