Optetrak Posterior Stabilized Versus Optetrak Hi-Flex

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the differences in clinical outcomes between the Optetrak® Posterior Stabilized (Optetrak® PS, Exactech, Gainesville, FL) and the Optetrak® Hi-Flex™ (Optetrak® HF, Exactech, Gainesville, FL) knee designs.

Detailed Description
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The purpose of this study is to evaluate the differences in clinical outcomes between the Optetrak® Posterior Stabilized (Optetrak® PS, Exactech, Gainesville, FL) and the Optetrak® Hi-Flex™ (Optetrak® HF, Exactech, Gainesville, FL) knee designs. The null hypothesis is that there is no difference in postoperative knee flexion between the Optetrak® PS and Optetrak® HF groups.

Official Title
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Prospective, Single-center, Non-randomized, Consecutive Series Study Comparing Functional Differences Between a Standard Posterior Stabilized TKR and a High-flexion Posterior Stabilized TKR

Conditions
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Arthropathy of Knee, Arthritis and/or Post-traumatic Degenerative Problems

Intervention / Treatment
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* Device: Optetrak PS
* Device: Optetrak Hi-Flex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is indicated for total knee replacement with a posterior stabilized device. Patient is between the ages of 50 and 80 years old Patient has a Body Mass Index (BMI) < 35.0 using the following method (or comparable method) • BMI = Weight (lbs.) ÷ Height (in.)2 x 703 Patient is skeletally mature. Patient is willing to participate by complying with pre and postoperative visit requirements, over at least a 1-year period, including completion of studyrequired questionnaires. Patient is willing and able to review and sign a study Informed Consent. Exclusion Criteria: Patient has a Body Mass Index (BMI) > 35.0 using the following method (or comparable method) • BMI = Weight (lbs.) ÷ Height (in.)2 x 703 Patient is skeletally mature Patient is willing to participate by complying with pre and postoperative visit requirements, over at least a 1-year period, including completion of study required questionnaires. Patient is willing and able to review and sign a study Informed Consent.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Optetrak Posterior Stabilized TKR<br>Subjects in this arm will receive an Optetrak Posterior Stabilized total knee system. | Device: Optetrak PS<br>* Optetrak Posterior Stabilized total knee replacement<br>|
| Active Comparator: Optetrak Hi-Flex TKR<br>Subjects in this arm will receive an Optetrak Hi-Flex total knee system. | Device: Optetrak Hi-Flex<br>* Optetrak Hi-Flex total knee replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome of interest is knee range of motion (ROM), specifically the degree of flexion. | Physician assess range of motion in knee joint | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Score (KSS) | Validated physician assessed outcome | 2 years | 
| Hospital for Special Surgery (HSS) Knee Score | Validated physician assessed outcome | 2 years | 
| Patient Satisfaction | Visual Analog Scale (1-10) where 10 is best. | 2 years | 
| Implant survivorship | Implant survivorship | 2 years | 
| Radiographic evaluation | Radiographic analysis | 2 years | 
| Complications | Adverse Events | 2 years |