Status:
WITHDRAWN
Post-Market Study of the EPIK Knee System
Lead Sponsor:
Encore Medical, L.P.
Conditions:
Osteoarthritis
Post Traumatic Degenerative Disease
Eligibility:
All Genders
18-60 years
Brief Summary
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
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 k...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01464632
Start Date
November 1 2011
End Date
May 1 2012
Last Update
May 16 2012
Active Locations (1)
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1
Hill Country Sports Medicine
Kyle, Texas, United States, 78640