Triathlon Tritanium Cone Augments Outcomes Study

Not Applicable

Active, not recruiting

• Conditions: Arthroplasty; Knee; Replacement

• 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
• Primary Completion: 2025-03-31
• Last Update Submitted: 2025-05-25
• Last Update Posted: 2025-05-30
• Study Completion: 2028-03-31

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

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)

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

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

Bluegrass Orthopaedics; 🇺🇸 Lexington, Kentucky, United States

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

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

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

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

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

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