Post-Market Study of the EPIK Knee System

Study Overview
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Brief Summary
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The purpose of this study is to determine the short-term (2 yr) and midterm (5 yr) cumulative revision rates of the EPIK™ Uni-compartmental Knee System.

Detailed Description
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Medial uni-compartmental knee replacement (UKA) has been used for over 40 years to treat osteoarthritis (OA) of the knee. It is becoming more widely accepted as a treatment for early stage OA of the knee in order to preserve bony and ligamentous structures. The majority of the subjects who have received this knee are older (over 65 yrs) however, it is being used increasingly more frequently in younger individuals who have uni-compartmental knee disease so that bone may be spared in case the need arises in the future for a total knee arthroplasty. The study will take place at two sites within the United States and be managed by the Clinical Affairs Department at DJO Surgical in Austin, TX. The study will include only subjects who meet the indications for use criteria for the EPIK™ Uni-compartmental Knee System and who are candidates for UKA. Investigators will enroll up to 60 subjects at each of 2 sites within the United States, for a total of 100 subjects maximum.

Official Title
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Prospective, Open Label Study of the Short-and Midterm Safety and Efficacy of the EPIK Uni-Compartmental Knee System in Community Practice

Conditions
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Osteoarthritis, Post Traumatic Degenerative Disease

Intervention / Treatment
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* Device: EPIK™ uni-compartmental knee


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet the indications for use of the EPIK Uni-compartmental knee system Must be a primary surgery Have a primary diagnosis of OA in the medial knee compartment Have active and passive flexion > 90º Have a fixed flexion contracture < 10º Have an intact ACL and PCL Be a primary, unilateral surgery Have BMI ≤ 35.00 Must not have infection (or history of infection within last 3 months), chronic or acute, local or systemic Must not be pregnant Be willing and able to sign the informed consent Be willing to follow study procedures, including all follow up visits Be over 18 years of age (≥ 18) and 60 years or younger (≤ 60) at time of consent Exclusion Criteria: Prior total or uni-knee arthroplasty (must be a primary surgery) Patello-femoral joint symptoms Bilateral surgical procedures BMI > 35.00 Muscular, neurological or vascular deficiencies which compromise the affected extremity Insufficient bone quality which may affect the stability of the implant Infection (or history of infection within last 3 months), chronic or acute, local or systemic Is younger than 18 years of age (<18) or over 60 (>60) years of age Mental conditions that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements High levels of physical activity (ex. Competitive sports, heavy physical labor) Documented (active) alcohol or drug addictions Loss of ligamentous structures Prisoner Metals sensitivity Subject is pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Primary<br>Post Market Study | Device: EPIK™ uni-compartmental knee<br>* This device is intended for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity, or revision of previous arthroplasty.<br>* Other names: EPIK;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revision Rate Post Surgery | To determine the number of revisions that occur to total knee replacements after receiving the uni-compartmental knee replaceement. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revision rate post surgery | To determine the number of revisions that occur to total knee replacements after receiving the uni-compartmental knee replaceement. | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medial knee replacement