Triathlon All-Polyethylene Tibia Outcomes Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the clinical functional results of the Triathlon All-Polyethylene Tibia Knee Device.

Detailed Description
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After being informed about the study, all patients giving written consent will undergo a screening period to determine eligibility for the study. If eligibility is met, data will be obtained retrospectively from the medical records from the preoperative to shortly after surgery time period. Thereafter, the subject will be evaluated at their 5-year and 10-year post surgery anniversary date.

Official Title
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A Retrospectively Enrolled and Prospectively Followed, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon All-Polyethylene Tibia

Conditions
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Arthropathy of Knee, Replacement, Knee Arthritis

Intervention / Treatment
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* Device: Triathlon All-Polyethylene Tibia Knee


Participation Criteria
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Eligibility Criteria
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Inclusions: Patient underwent primary TKA and is currently implanted with the Triathlon All- Polyethylene Tibia as well as compatible Stryker femoral and patellar components with no pending revision or removal. Patient has signed an IRB-approved, study specific Informed Patient Consent Form. Patient is a male or non-pregnant female and is 18 years of age or older at the time of study device implantation. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations. Exclusions: Patient had an active or suspected latent infection in or about the affected knee joint at time of study device implantation. Patient had distant foci of infection which could have caused hematogenous spread to the implant site at time of study device implantation. Patient was skeletally immature at time of study device implantation. Patient has a mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care. Patient's bone stock was compromised by disease, infection, or prior implantation which cannot provide adequate support and/or fixation to the prosthesis. Patient had severe instability of the knee joint secondary to the absence of collateral ligament integrity and function. Patient was immunologically suppressed or receiving steroids in excess of normal physiological requirements at the time of surgery (e.g. > 30 days). 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 All-Polyethylene Tibia Knee<br>All subjects enrolled will have received the Triathlon All-Polyethylene Tibia Knee device. | Device: Triathlon All-Polyethylene Tibia Knee<br>* Triathlon All-Polyethylene Tibia Knee is an all polyethylene resurfacing knee device using either a condylar stabilizing (CS) and posterior stabilizing (PS) device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Score (KSS) Function | The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome postoperative. | 10-years postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kaplan-Meier Survival Analysis | To present 10-year Kaplan-Meier survival analysis for the Triathlon APT | 10-years postoperative |