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
1 other identifier
interventional
254
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2015
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedFirst Posted
Study publicly available on registry
August 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedResults Posted
Study results publicly available
June 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
ExpectedJune 1, 2026
December 1, 2025
9.7 years
July 31, 2015
March 26, 2026
May 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Location and Severity of End-of-stem Pain.
2 year
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Intraoperative
Study Arms (1)
Triathlon Tritanium Cone Augments
OTHERCases who receive the Triathlon TS Total Knee System with at least one Triathlon Tritanium Cone Augment.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Orlando Health
Zephyrhills, Florida, 33542, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Bluegrass Orthopaedics
Lexington, Kentucky, 40509, United States
The CORE Institute
Novi, Michigan, 48374, United States
Michigan Heart, St. Joseph Health System
Ypsilanti, Michigan, 48197, United States
Missouri Orthopaedic Institute
Columbia, Missouri, 65212, United States
Rothman Institute
Egg Harbor, New Jersey, 08234, United States
The Orthopaedic Center
Tulsa, Oklahoma, 74104, United States
Providence Medical Research Center
Spokane, Washington, 99208, United States
Results Point of Contact
- Title
- Alexandra Valentino, Manager Clinical Research
- Organization
- Stryker
Study Officials
- 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
Craig Della Valle, MD
Rush University Medical Center
- PRINCIPAL INVESTIGATOR
Ajay Aggarwal, MD
Missouri Orthopaedic 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2015
First Posted
August 13, 2015
Study Start
August 1, 2015
Primary Completion
March 31, 2025
Study Completion (Estimated)
March 31, 2028
Last Updated
June 1, 2026
Results First Posted
June 1, 2026
Record last verified: 2025-12