NCT06379321

Evaluation of Outcomes of the Triathlon Hinge Knee (THK) System

A Retrospective/Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon Hinge Knee (THK) System

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

This study is a prospectively and retrospectively enrolled, post-market, open-label, non-randomized, single institution evaluation of clinical outcomes of primary or revision knee surgery patients who meet the eligibility criteria and received devices from the Triathlon Hinge Knee System according to its indications for use (IFU). Clinical evaluation for all cases will include data collection of patient demographics, surgical details, early postoperative status, functional and clinical outcomes, and survivorship at 1, 2, 6, and 10-years.

Detailed description

The purpose of this study is to evaluate the safety and performance of the Triathlon Hinge Knee System for both primary and revision cases in accordance with the Indications for Use. The main objective of this study is to determine (1) mid- (5 year) and long-term (10 year) survivorship, and (2) drivers of failure for the Triathlon Hinge Knee (THK) hinge. Data from this study will be used to develop a predictive model to identify the most important factors in achieving fixation, including the role of augments, cones, thresholds for cement mantle thickness, and number of zones of fixation required for survivorship. Survivorship is defined as the absence of aseptic revision to the implanted device. The Triathlon Hinge Knee System consists of Triathlon Hinge femoral components, the Triathlon Revision baseplate, Triathlon Revision Tibial Augments, Triathlon Hinge Femoral Distal Augments, Triathlon Hinge Insert, Triathlon Revision Insert X3, and Triathlon Hinge Bumpers, Axle, Bushings, Tibial Sleeve, and Bearing component. It is designed to be a single platform for revision, difficult primary, and limb salvage surgeries.

Conditions

• Knee Arthropathy
• Recurrence
• Knee Infection

Interventions

Type	Name	Description
DEVICE	Triathlon Hinge Knee (THK) System	Participants receive Triathlon Hinge Knee (THK) System during primary or revision knee arthroplasty in accordance with the indications for use

Timeline

• Start date: 2024-05-10
• Primary completion: 2034-05-10
• Completion: 2034-05-10
• First posted: 2024-04-23
• Last updated: 2026-03-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study