Clinical Trial: Investigation of a Customized Femoral Resurfacing Implant
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Investigation of a Customized Femoral Resurfacing Implant (Episealer® Knee Condyle Device) to Assess the Safety Profile and Performance for 2 Years Post-operatively
Brief Summary: The purpose is to assess the safety profile and performance of a femoral resurfacing implant for localized chondral lesions.
Detailed Summary: The implant's safety profile will be assessed by incidence of any subject having any of the seven identified implant-related clinical undesirable side effects. This will be analyzed with a one-side exact binomial test on significance level 0.05, at 24 months post-operatively.
Sponsor: Episurf Medical AB
Current Primary Outcome: Number of participants with Adverse Events [ Time Frame: 24 months ]
Original Primary Outcome: Safety [ Time Frame: 24 months ]
Current Secondary Outcome: Clinical performance [ Time Frame: 24 months ]
Original Secondary Outcome: Same as current
Information By: Episurf Medical AB
Dates:
Date Received: August 10, 2012
Date Started: December 2012
Date Completion: February 2018
Last Updated: February 23, 2015
Last Verified: February 2015