Triathlon Tritanium Cone Augments Outcomes Study

Not Applicable

Active, not recruiting

• Conditions: Arthroplasty; Knee; Replacement
• Interventions: Device: Triathlon Tritanium Cone Augments

• Registration Number: NCT02521103
• Lead Sponsor: Stryker Orthopaedics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-31
• Study Start: 2015-08
• Study First Submitted QC: 2015-08-11
• Study First Posted: 2015-08-13
• Status Verified: 2024-11
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-26
• Primary Completion: 2025-04
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 145

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of cases with revision of the Femoral Cone Augment or Tibial Cone Augment for aseptic loosening	2 year

Secondary Outcome Measures

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

Trial Locations

Locations (9)

The CORE Institute; 🇺🇸 Novi, Michigan, United States

Bluegrass Orthopaedics; 🇺🇸 Lexington, Kentucky, United States

Florida Medical Clinic; 🇺🇸 Zephyrhills, Florida, United States

The Orthopaedic Center; 🇺🇸 Tulsa, Oklahoma, United States

Rothman Institute; 🇺🇸 Egg Harbor Township, New Jersey, United States

Missouri Orthopaedic Institute; 🇺🇸 Columbia, Missouri, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Providence Medical Research Center; 🇺🇸 Spokane, Washington, United States

Michigan Heart, St. Joseph Health System; 🇺🇸 Ypsilanti, Michigan, United States