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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 145
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Filesha Haniff; Email: filesha.haniff@stryker.com

Study Locations

• United States
  • Florida
    • Zephyrhills, Florida, United States, 33542
      • Florida Medical Clinic
  • 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 Township, 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 primary or revision TKA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of cases with revision of the Femoral Cone Augment or Tibial Cone Augment for aseptic loosening	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of end-of-stem pain in relation to the Triathlon Tritanium Cone Augments location.	End-of-stem pain is determined via a patient questionnaire; 2 questions are asked in regard to shin and thigh pain location.	2 year
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 Femoral Cone Augment size.	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
Anderson Orthopaedic Research Institute (AORI) classification and Tibial Symmetric Cone Augment size.	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
Anderson Orthopaedic Research Institute (AORI) classification and Tibial Asymmetric Cone Augment size.	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

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2033

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): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 76