NCT02521103

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Aug 2015Mar 2028

First Submitted

Initial submission to the registry

July 31, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Expected
Last Updated

December 5, 2025

Status Verified

December 1, 2025

Enrollment Period

9.7 years

First QC Date

July 31, 2015

Last Update Submit

December 4, 2025

Conditions

ArthroplastyReplacementKnee

Outcome Measures

Primary Outcomes (1)

  • Percentage of cases with revision of the Femoral Cone Augment or Tibial Cone Augment for aseptic loosening

    2 year

Secondary Outcomes (5)

  • Presence of end-of-stem pain in relation to the Triathlon Tritanium Cone Augments location.

    2 year

  • Severity of end-of-stem pain.

    2 year

  • Anderson Orthopaedic Research Institute (AORI) classification and Femoral Cone Augment size.

    intraoperative

  • Anderson Orthopaedic Research Institute (AORI) classification and Tibial Symmetric Cone Augment size.

    intraoperative

  • Anderson Orthopaedic Research Institute (AORI) classification and Tibial Asymmetric Cone Augment size.

    intraoperative

Study Arms (1)

Triathlon Tritanium Cone Augments

OTHER

Cases who receive the Triathlon TS Total Knee System with at least one Triathlon Tritanium Cone Augment

Device: Triathlon Tritanium Cone Augments

Interventions

Triathlon Tritanium Cone AugmentsDEVICE

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

Triathlon Tritanium Cone Augments

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Florida Medical Clinic

Zephyrhills, Florida, 33542, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Bluegrass Orthopaedics

Lexington, Kentucky, 40509, United States

Location

The CORE Institute

Novi, Michigan, 48374, United States

Location

Michigan Heart, St. Joseph Health System

Ypsilanti, Michigan, 48197, United States

Location

Missouri Orthopaedic Institute

Columbia, Missouri, 65212, United States

Location

Rothman Institute

Egg Harbor, New Jersey, 08234, United States

Location

The Orthopaedic Center

Tulsa, Oklahoma, 74104, United States

Location

Providence Medical Research Center

Spokane, Washington, 99208, United States

Location

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

December 5, 2025

Record last verified: 2025-12

Locations

US(9)