Optetrak Knee System Post Market Clinical Follow-Up

Study Overview
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Brief Summary
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A Post-Market Domestic (US) and International Data Collection to Assess the Optetrak Knee System

Detailed Description
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Patient outcomes data is important for assessing the post-market safety and effectiveness of orthopedic medical devices. The purpose of this study is to collect clinical and patient outcomes and survivorship data for patients who have received or will receive a Optetrak® knee prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA).

Official Title
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A Post-Market Domestic (US) and International Data Collection to Assess the Optetrak Knee System

Conditions
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Knee Arthroplasty, Total

Intervention / Treatment
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* Device: Optetrak Total Knee System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is indicated for knee replacement, or has already undergone knee replacement, with a device manufactured or distributed by Exactech Patient is skeletally mature Patient meets the indications detailed in the applicable product package insert Patient is willing and able to review and sign an informed consent form, if necessary Exclusion Criteria: Patient has a local or systemic infection Patient has a known sensitivity to one or more of the materials in the knee replacement system to be used Patient is pregnant Patient has a mental or physical condition that may invalidate evaluation of the data - --- Patient is a prisoner Surgery is contraindicated according to the applicable product package insert

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Enrolled Subjects<br>Patients recruited from the population undergoing knee arthroplasty as part of standard of care. Patients who meet all the inclusion criteria and none of the exclusion criteria should be presented with an opportunity to undergo the informed consent process. | Device: Optetrak Total Knee System<br>* Total Knee Arthroplasty using Exactech's Optetrak branded components.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Score | (KSS) - validated outcome score | Preoperative | 
| Knee Society Score | (KSS) - validated outcome score | 6 month postoperative | 
| Knee Society Score | (KSS) - validated outcome score | annually through study completion, maximum of 10-years | 
| Hospital for Special Surgery Knee Score | (HSS) - validated outcome score | Preoperative | 
| Hospital for Special Surgery Knee Score | (HSS) - validated outcome score | 6 month postoperative | 
| Hospital for Special Surgery Knee Score | (HSS) - validated outcome score | annually through study completion, maximum of 10-years | 
| Oxford Knee Score | (OKS) - validated outcome score | Preoperative | 
| Oxford Knee Score | (OKS) - validated outcome score | 6 month postoperative | 
| Oxford Knee Score | (OKS) - validated outcome score | annually through study completion, maximum of 10-years |