Post-Market Study of the EPIK Knee System

Withdrawn before enrolling

Conditions studied: Osteoarthritis, Post Traumatic Degenerative Disease

In brief

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.

Key facts

Study ID

NCT01464632

Run by

Encore Medical, L.P.

People needed

0

Starts

2011-11-01

Expected to finish

2012-05-01

Last updated by the study team

2012-05-16

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hill Country Sports Medicine — Kyle, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.