This study is to compare 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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
233
Surgical procedure which creates a marrow clot in the prepare cartilage defect.
combination product- biologic (autologous chondrocytes) /device (scaffold) implant
Knee injury and Osteoarthritis Outcome Score (KOOS) - Pain Subdomain
As measured by a change in KOOS (pain subdomain) score at 24 months from baseline
Time frame: 24 months post treatment
Knee injury and Osteoarthritis Outcome Score (KOOS) - Function Subdomain
As measured by a change in KOOS score (activity of daily living subdomain) at 24 months from baseline
Time frame: 24 months post treatment
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