NOVOCART®3D for Treatment of Articular Cartilage of the Knee (N3D)
This study is to NOVOCART 3D relative to Microfracture for the treatment of knee cartilage defects. Efficacy will be evaluated by both pain and function. Safety will also be evaluated.
Articular Cartilage of the Femoral Condyle Between 4-6cm2
Biological: NOVOCART 3D
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 3, Prospective, Randomized, Partially Blinded Multi-Center Study to Measure the Safety and Efficacy of NOVOCART 3D Compared ot Microfracture in Teh Treatment of Articular Cartilage Defects|
- Pain [ Time Frame: 24 months post treatment ] [ Designated as safety issue: Yes ]As measured by change in score from Baseline in KOOS score
- Function [ Time Frame: 24 months post treatment ] [ Designated as safety issue: No ]As measured by change in score from Baseline in KOOS score
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||August 2021|
|Estimated Primary Completion Date:||July 2018 (Final data collection date for primary outcome measure)|
Experimental: NOVOCART 3D
Scaffold assisted autologous chondrocyte Implant
|Biological: NOVOCART 3D|
Active Comparator: Microfracture
considered a typical treatment for articular cartilage repair
Surgical procedure which creates a marrow clot in the prepare cartilage defect.
Subjects with articular knee defects will be randomized to receive either Microfracture or NOVOCART 3D. Subjects will be followed for five years in total and will be evaluated for safety and efficacy.