The objective of this study is to compare the efficacy and safety of MACI® vs arthroscopic microfracture in the treatment of participants aged 10 to 17 years with symptomatic articular chondral or osteochondral defects of the knee.
Age 10 to 17 years at the time of planned randomization
Symptomatic cartilage or osteochondral defects
One or more International Cartilage Repair Society (ICRS) Grade III or IV chondral or unsalvageable osteochondral defects located on the femoral condyles and/or trochlea amenable to treatment with the surgical procedure determined at randomization (MACI or microfracture).
Concurrent ICRS Grade I and II defects are acceptable on the tibia if they remain untreated (or are treated with debridement only) at the time of study treatment.
At least 1 defect size ≥1.5 cm2 on the patella, femoral condyles and/or the trochlea; defects include OCD lesions with a bone lesion depth of ≤6 mm and does not require a bone graft.
Salvageable OCD lesions must have failed prior conservative and a reparative treatment, and the participant still experiences pain associated with the osteochondral lesion. Participants with defects as a result of trauma or unknown etiology are eligible regardless of prior treatments.
Stable target knee (i.e., anterior and posterior cruciate ligaments should be free of laxity as well as stable and intact). Ligament repair or reconstruction procedures are allowed prior to screening arthroscopy.
Intact meniscus or partial meniscus (at least 50% of functional meniscus remaining) in the target knee. Meniscal repair or resection might be performed either staged or concurrent with the cartilage repair procedure provided that the surgeon was able to confirm that at least 50% of functional meniscus would remain after the corrective meniscal treatment.
Parallel
MACI
Biological/Vaccineautologous cultured chondrocytes on porcine collagen membrane
microfracture
Procedure/SurgeryArthroscopic microfracture treatment
Proportion of Participants Who Achieve ≥ 10-point Improvement From Baseline in KOOS-Child Pain and Function (Sports and Recreational Activities) Subscale Scores
A responder is defined as a participant with ≥ 10-point change (improvement) in both the KOOS-Child Pain and Function (Sports and Recreational activities) scores from Baseline scores. The Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) is a validated knee-specific instrument developed to assess the participant's opinion of their knee and associated problems. KOOS consists of 5 subscales: Pain, Function in sports and recreational activities, other Symptoms, Function in activities of daily living (ADL), and knee related Quality of life (QOL).
Change from Baseline in KOOS-Child subscores
The Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) is a validated knee-specific instrument developed to assess the participant's opinion of their knee and associated problems. KOOS consists of 5 subscales: Pain, Function in sports and recreational activities, other Symptoms, Function in activities of daily living (ADL), and knee related Quality of life (QOL).
Change from Baseline in KOOS-Child subscores
The Knee and Osteoarthritis Outcome Score for Children (KOOS-Child) is a validated knee-specific instrument developed to assess the participant's opinion of their knee and associated problems. KOOS consists of 5 subscales: Pain, Function in sports and recreational activities, other Symptoms, Function in activities of daily living (ADL), and knee related Quality of life (QOL).
Treatment Emergent Adverse Events
A treatment emergent untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
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