Osteoarthritis Clinical Trial
— EPIKOfficial title:
Prospective, Open Label Study of the Short-and Midterm Safety and Efficacy of the EPIK Uni-Compartmental Knee System in Community Practice
Verified date | May 2012 |
Source | Encore Medical, L.P. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Hill Country Sports Medicine | Kyle | Texas |
Lead Sponsor | Collaborator |
---|---|
Encore Medical, L.P. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | 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 | Yes |
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