Articular Cartilage Disorder Clinical Trial
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
The purpose is to assess the safety profile and performance of a femoral resurfacing implant for localized chondral lesions.
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. ;
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