Triathlon Tritanium Cone Augments Outcomes Study

Summary

The purpose of this study was to evaluate the success rate of the Triathlon Tritanium Cone Augment with the Triathlon TS Total Knee System at 2 years postoperative, defined as absence of revision of the Femoral Cone Augment or Tibial Cone augment for aseptic loosening.

Conditions

• Arthroplasty
• Replacement
• Knee

Interventions

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 revision TKA.

Sponsors & Collaborators

• Stryker Orthopaedics

  lead INDUSTRY

Principal Investigators

• Alvin Ong, MD · Rothman Institute

• Michael Masini, MD · Michigan Heart, St. Joseph Health System

• Yogesh Mittal, MD · The Orthopaedic Center

• David Markel, MD · The CORE Institute

• Craig Della Valle, MD · Rush University Medical Center

• Ajay Aggarwal, MD · Missouri Orthopaedic Institute

• Louis S Stryker, MD · The University of Texas Medical Branch (UTMB)

• Edward J Stolarski, MD · Gulfcoast Research Institute

• Joshua Drumm, DO · Providence Medical Research Center

• Gerald E Alexander, MD · Orlando Health

• Kevin Denehy, MD · Bluegrass Orthopaedics

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-08-31

Primary Completion

2025-03-31

Completion

2028-03-31

FDA Device

Yes

Countries

• United States

Study Locations