RECRUITINGPhase 3INTERVENTIONAL
A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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).
- At least 1 defect size ≥1.5 cm2 on the 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.
- 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.
Who Should NOT Join This Trial:
- Any surgery on the target knee joint within 6 months prior to Screening (not including diagnostic arthroscopy)
- ICRS Grade III or IV chondral or unsalvageable osteochondral defects located on the patella or tibia or any lesion that is bipolar to the index lesion
- Concomitant inflammatory disease or other conditions that affects the joints (eg, rheumatoid arthritis, metabolic bone disease, psoriasis, symptomatic chondrocalcinosis)
- Known history of septic arthritis in the index knee joint
- Known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin
- Females who are pregnant or lactating
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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 determined at randomization (MACI or microfracture).
* At least 1 defect size ≥1.5 cm2 on the 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.
* 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.
Exclusion Criteria:
* Any surgery on the target knee joint within 6 months prior to Screening (not including diagnostic arthroscopy)
* ICRS Grade III or IV chondral or unsalvageable osteochondral defects located on the patella or tibia or any lesion that is bipolar to the index lesion
* Concomitant inflammatory disease or other conditions that affects the joints (eg, rheumatoid arthritis, metabolic bone disease, psoriasis, symptomatic chondrocalcinosis)
* Known history of septic arthritis in the index knee joint
* Known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin
* Females who are pregnant or lactating
Treatments Being Tested
BIOLOGICAL
MACI
autologous cultured chondrocytes on porcine collagen membrane
PROCEDURE
microfracture
Arthroscopic microfracture treatment
Locations (12)
Stanford University
Palo Alto, California, United States
Shriner's Hospital for Children Northern California
Sacramento, California, United States
University of California Davis Health
Sacramento, California, United States
Ochsner Sports Medicine Institute
New Orleans, Louisiana, United States
Johns Hopkins Outpatient Center
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Akron Children's Hospital
Akron, Ohio, United States
The Ohio State University Jameson Crane Sports Medicine Institute
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Penn Sports Medicine Center
Philadelphia, Pennsylvania, United States
Texas Children's Hospital
Houston, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States