A Prospective, Open-label, Randomized, Concurrent Active-controlled, Longitudinal, Multicenter, Phase 3 Clinical Study of the Safety and Efficacy of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee (PEAK)

NCT03588975 Phase 3 RECRUITING

The objective of this study is to compare the efficacy and safety of MACI® vs arthroscopic microfracture in the treatment of patients aged 10 to 17 years with symptomatic articular chondral or osteochondral defects of the knee.

Details

Lead sponsor	Vericel Corporation
Phase	Phase 3
Status	RECRUITING
Enrolment	45
Start date	2018-10-24
Completion	2027-06

Conditions

• Chondral Defect
• Osteochondritis Dissecans (OCD)
• Articular Cartilage Defect
• Articular Cartilage Disorder of Knee

Interventions

• MACI
• microfracture

Primary outcomes

• Proportion of Patients Who Achieve at Least a 10-point Improvement From Baseline in KOOS-Child Pain and Function (Sports and Recreational Activities) Scores — Baseline and Week 104
  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).

Countries

United States