Triathlon PSR 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 Total Knee System using the Triathlon PSR Tibial Insert for primary total knee arthroplasty (TKA) in a consecutive series of patients who meet the eligibility criteria. The SF-36 score of subjects receiving the Triathlon Total Knee with the Triathlon PSR insert is expected to be comparable with that of subjects receiving historical Triathlon PS cemented constructs.

Official Title
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A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon Total Knee System Using the Triathlon PSR Tibial Insert

Conditions
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Arthroplasty, Knee

Intervention / Treatment
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* Device: Triathlon PSR Tibial Insert


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has signed an IRB/EC approved; study specific Informed Patient Consent Form. Patient is a male or non-pregnant female, skeletally mature, age 18-75 years at time of study device implantation. Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD). Patient is a candidate for primary cemented 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 is already participating in the study for a contralateral total knee replacement. Patient has a diagnosis of avascular necrosis or inflammatory arthritis. Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation. Patient has any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care. Patient has a compromised bone stock which cannot provide adequate support to the prosthesis. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days). Patient is diagnosed with lumbar radicular pain. Patient has severe instability of the knee joint secondary to the absence of collateral ligament integrity and function. Patient has a known sensitivity to device materials. Patient is a prisoner.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 PSR Tibial Insert<br>Cases receiving a Triathlon Total Knee with the Triathlon PSR Tibial Insert | Device: Triathlon PSR Tibial Insert<br>* The Triathlon PSR Tibial Insert is intended to be used as a component in primary TKA and is designed to reduce rotational constraint at deep flexion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean SF-36 Physical Component Score | The SF-36 is a 36-item patient completed questionnaire to measure general health and well-being. It includes physical and mental status component sub scores; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state. | pre-operative, 6 weeks, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EuroQol-5 Dimension (EQ-5D) | The EuroQol-5 Dimension (EQ-5D) is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; EQ-5D descriptive system and the visual analogue scale (VAS). The EQ-5D descriptive system comprises the following five dimensions: mobility self care, usual activities, pain/comfort and anxiety/depression. Each dimension has 3 levels indicating no problems, some problems or extreme problems. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health and a high score shows better health. With the EQ VAS the respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status). | PreOp, 6 week, 1 year | 
| Range of Motion | Range of Motion evaluates how much the knee can be bent and straightened. The normal range of motion is typically 0 to 135 degrees. | PreOp, 6 weeks, 1 year | 
| Survivorship of Triathlon PSR Insert | All-cause survivorship of the Triathlon PSR Tibial Insert will be evaluated through 10 year. | 1 Year |