Triathlon Tritanium Cone Augments Outcomes Study

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon TS Total Knee System With Triathlon Tritanium Cone Augments

Conditions
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Replacement, Arthroplasty, Knee

Intervention / Treatment
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* Device: Triathlon Tritanium Cone Augments


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Triathlon Tritanium Cone Augments<br>Cases who receive the Triathlon TS Total Knee System with at least one Triathlon Tritanium Cone Augment | Device: Triathlon Tritanium Cone Augments<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |