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.
This is a 2-year prospective, multicenter, randomized, open-label, parallel group clinical trial; a total of 45 participants, ages 10 to 17 years, will be randomized to receive a 1-time treatment with MACI or microfracture (2:1, 30 MACI:15 microfracture). After meeting screening criteria at the initial visit, all participants will have a screening arthroscopy to further assess study eligibility. During the screening arthroscopy, participants will be further evaluated against entry criteria. Cartilage lesion size will be measured prior to any cartilage repair procedure and randomization. All participants who meet the eligibility criteria and are considered suitable for treatment in the study will have a cartilage biopsy taken prior to randomization to study treatment. Eligible participants will be randomized during the screening arthroscopy procedure to receive either MACI or microfracture treatment. Participants randomized to microfracture will undergo the procedure during the screening arthroscopy. All biopsied tissue will be sent to the Vericel manufacturing facility in Massachusetts, where the sample will be processed to isolate the autologous chondrocytes. Cells from participants randomized to the MACI group will be used in the preparation of the MACI implant; cells from participants randomized to the microfracture group will be cryopreserved. Participants randomized to treatment with MACI will return within 12 weeks of the screening arthroscopy to undergo the chondrocyte implantation procedure via arthrotomy. Participants are to follow a recommended postoperative rehabilitation program and compliance with the rehabilitation schedule will be monitored. Participants will be followed post-study treatment for 2 years (104 Weeks).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
autologous cultured chondrocytes on porcine collagen membrane
Arthroscopic microfracture treatment
Stanford University School of Medicine
Palo Alto, California, United States
RECRUITINGShriners Hospital for Children Northern California
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).
Time frame: Baseline and Week 104
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).
Time frame: Baseline and Week 104
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).
Time frame: Baseline and Week 52
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Enrollment
45
Sacramento, California, United States
University of California Davis Health
Sacramento, California, United States
RECRUITINGOchsner Sports Medicine Institute
New Orleans, Louisiana, United States
RECRUITINGJohns Hopkins Outpatient Center
Baltimore, Maryland, United States
RECRUITINGUniversity of Michigan Medsport Orthopaedic Surgery
Ann Arbor, Michigan, United States
RECRUITINGMontefiore Medical Center/Albert Einstein College of Medicine
The Bronx, New York, United States
COMPLETEDAkron Children's Hospital
Akron, Ohio, United States
RECRUITINGThe Ohio State University Jameson Crane Sports Medicine Institute
Columbus, Ohio, United States
RECRUITINGPenn Medicine University City
Philadelphia, Pennsylvania, United States
RECRUITING...and 4 more locations