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 ]

The primary efficacy analysis in this study is to ascertain that the incidence of at least one subject having any of the seven identified clinical undesirable side effects is lower than 38 % (risk profile of the comparator) up to the 24 months analysis in the PP population. This will be analyzed with a one-side exact binomial test on significance level 0.05


Original Primary Outcome: Safety [ Time Frame: 24 months ]

The primary efficacy analysis in this study is to ascertain that the incidence of a subject having any of the seven identified clinical undesirable side effects is lower than 38 % (risk profile of the comparator) up to the 24 months analysis in the PP population. This will be analyzed with a one-side exact binomial test on significance level 0.05


Current Secondary Outcome: Clinical performance [ Time Frame: 24 months ]

Clinical performance, by questionnaires and knee ROM measurements.


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