NOVOCART 3D Treatment Following Microfracture Failure

Safety and Efficacy of NOVOCART 3D in the Treatment of Articular Cartilage Defects Following Failure on Microfracture

This study is prospective single arm extension study of protocol AAG-G-H-1220. It is open only to participants of AAG-G-H-1220 randomized to the Microfracture treatment group.

This study is an extension of protocol AAG-G-H-1220 wherein patients were randomized to either NOVOCART 3D or Microfracture treatment groups. This prospective single arm extension study is only open to participants of AAG-G-H-1220 who were randomized to Microfracture treatment and who failed Microfracture treatment.

Inclusion Criteria:

• participated in study AAG-G-H-1220
• identified as a microfracture failure patient
• voluntary consent to participate in the study

Exclusion Criteria:

• other cartilage repair procedures performed on target knee
• other conditions that would interfere with healing or evaluating outcomes
• lesions requiring implants larger than 9cm2
• non-compliance with requirements in study AAG-G-H-1220