Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03588975 | A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee | PHASE3 | RECRUITING | 45 | — | — | Oct 24, 2018 | Jun 1, 2027 | Dec 2, 2024 | 12 | United States |
A responder is defined as a participant with at least a 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 patients' 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).
| Arm | Type | Description |
|---|---|---|
| MACI | EXPERIMENTAL | autologous cultured chondrocytes on porcine collagen membrane |
| microfracture | ACTIVE_COMPARATOR | surgical procedure |
| Name | Type | Description |
|---|---|---|
| MACI | BIOLOGICAL | autologous cultured chondrocytes on porcine collagen membrane |
| microfracture | PROCEDURE | Arthroscopic microfracture treatment |
Inclusion Criteria: * 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 determin...