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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Arthroplasty; Knee; Replacement
• Intervention / Treatment: Device: Triathlon Tritanium Cone Augments

Detailed Description

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. The total enrollment goal for the study is 145 cases have received the Triathlon TS Total Knee System with a Triathlon Tritanium Cone Augment. Additionally, between 40-50 cases (within the study population) will receive the Triathlon TS Total Knee System with a Triathlon Tritanium Central Femoral Cone Augment.

• Study Type: Interventional
• Enrollment (Actual): 254
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Zephyrhills, Florida, United States, 33542
      • Orlando Health
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Bluegrass Orthopaedics
  • Michigan
    • Novi, Michigan, United States, 48374
      • The Core Institute
    • Ypsilanti, Michigan, United States, 48197
      • Michigan Heart, St. Joseph Health System
  • Missouri
    • Columbia, Missouri, United States, 65212
      • Missouri Orthopaedic Institute
  • New Jersey
    • Egg Harbor, New Jersey, United States, 08234
      • Rothman Institute
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • The Orthopaedic Center
  • Washington
    • Spokane, Washington, United States, 99208
      • Providence Medical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient has signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved, study specific Informed Patient Consent Form.
• Patient is a male or non-pregnant female, skeletally mature and age 18 years or older at time of study device implantation.
• Patient is a candidate for revision of all femoral and tibial components of a total knee replacement.
• Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

• Patient has a Body Mass Index (BMI) > 45.
• Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
• Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
• Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration.
• Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
• Patient has a failed unicondylar knee prosthesis.
• Patient has a known sensitivity to device materials.
• Patient is a prisoner.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Triathlon Tritanium Cone Augments; Cases who receive the Triathlon TS Total Knee System with at least one Triathlon Tritanium Cone Augment.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cases With Revision of the Femoral Cone Augment or Tibial Cone Augment for Aseptic Loosening.	The primary efficacy parameter is the revision/removal of femoral cone augment or tibial cone augment for aseptic loosening at 2 years postoperative. Success at 2 years is defined as no incidence of revision/removal of femoral or tibial cone augment for aseptic loosening within 2 years.	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Location and Severity of End-of-stem Pain.	End-of-stem pain is determined via a patient questionnaire; 2 questions are asked in regard to shin and thigh pain. Pain for both the shin and thigh are identified using the following categories: no pain; pain with extreme activity only; pain with moderate activity; pain with normal activity; pain at rest	2 year
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.	The AORI is a bone defect classification which consists of four Types: Type I: Metaphyseal bone is intact, with minor bone defects not compromising component stability. Type IIA: There is metaphyseal bone damage and cancellous bone loss in one femoral/tibial condyle; cement reinforcement, bone grafting or metal augmentation is needed. Type IIB: There is metaphyseal bone damage and cancellous bone loss in both femoral/tibial condyles; cement reinforcement, bone grafting or metal augmentation is needed. Type III: The metaphyseal bone is deficient and a structural allograft or a custom-made, hinged or revision prosthesis with an extended intramedullary stem is needed.	Intraoperative

Collaborators and Investigators

• Sponsor: Stryker Orthopaedics
• Investigators: Principal Investigator: Ajay Aggarwal, MD, Missouri Orthopaedic Institute; Principal Investigator: Craig Della Valle, MD, Rush University Medical Center; Principal Investigator: Alvin Ong, MD, Rothman Institute; Principal Investigator: Michael Masini, MD, Michigan Heart, St. Joseph Health System; Principal Investigator: Yogesh Mittal, MD, The Orthopaedic Center; Principal Investigator: David Markel, MD, The Core Institute; Principal Investigator: Louis S Stryker, MD, The University of Texas Medical Branch (UTMB); Principal Investigator: Edward J Stolarski, MD, Gulfcoast Research Institute; Principal Investigator: Joshua Drumm, DO, Providence Medical Research Center; Principal Investigator: Gerald E Alexander, MD, Orlando Health; Principal Investigator: Kevin Denehy, MD, Bluegrass Orthopaedics

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): March 31, 2025
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: July 31, 2015
• First Submitted That Met QC Criteria: August 11, 2015
• First Posted (Estimated): August 13, 2015

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 76

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes