Post-Market Study of the EPIK Knee System (EPIK)
|ClinicalTrials.gov Identifier: NCT01464632|
Recruitment Status : Withdrawn (Unable to enroll any study participants.)
First Posted : November 3, 2011
Last Update Posted : May 16, 2012
|Condition or disease||Intervention/treatment|
|Osteoarthritis Post Traumatic Degenerative Disease||Device: EPIK™ uni-compartmental knee|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Prospective, Open Label Study of the Short-and Midterm Safety and Efficacy of the EPIK Uni-Compartmental Knee System in Community Practice|
|Study Start Date :||November 2011|
|Primary Completion Date :||May 2012|
|Study Completion Date :||May 2012|
Post Market Study
Device: EPIK™ uni-compartmental knee
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.
Other Name: EPIK
- Revision Rate Post Surgery [ Time Frame: 5 years ]To determine the number of revisions that occur to total knee replacements after receiving the uni-compartmental knee replaceement.
- Revision rate post surgery [ Time Frame: 2 year ]To determine the number of revisions that occur to total knee replacements after receiving the uni-compartmental knee replaceement.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01464632
|United States, Texas|
|Hill Country Sports Medicine|
|Kyle, Texas, United States, 78640|
|Principal Investigator:||Christina M Sheely, D.O.||Hill Country Sports Medicine|