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.
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. The total enrollment goal for the study is 145 cases have received the Triathlon TS Total Knee System with a Triathlon Tritanium Cone Augment. Additionally, between 40-50 cases (within the study population) will receive the Triathlon TS Total Knee System with a Triathlon Tritanium Central Femoral Cone Augment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
254
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.
Orlando Health
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
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.
Time frame: 2 year
Location and 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
Time frame: 2 year
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
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.
Time frame: Intraoperative
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Michigan Heart, St. Joseph Health System
Ypsilanti, Michigan, United States
Missouri Orthopaedic Institute
Columbia, Missouri, United States
Rothman Institute
Egg Harbor, New Jersey, United States
The Orthopaedic Center
Tulsa, Oklahoma, United States
Providence Medical Research Center
Spokane, Washington, United States