Confirmatory Study of NeoCart in Knee Cartilage Repair
- Conditions
- Articular Cartilage Defects in the Knee Joint
- Interventions
- Biological: NeoCartProcedure: Microfracture
- Registration Number
- NCT01066702
- Lead Sponsor
- Histogenics Corporation
- Brief Summary
This confirmatory study is a prospective randomized trial comparing the efficacy and safety of an autologous chondrocyte tissue implant (NeoCart) to the surgical intervention microfracture in the treatment of cartilage defects in the knee.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 245
- greater than 18 years old
- symptomatic articular cartilage lesion of the femur and/or trochlea
- prior surgical intervention other than debridement
- arthritis
- clinically significant or symptomatic vascular or neurologic disorder of the lower extremities
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NeoCart NeoCart Autologous cartilagenous tissue implant Microfracture Microfracture surgical intervention
- Primary Outcome Measures
Name Time Method The change of physical functioning and pain as assessed by patient reported outcome measures (Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score) one year
- Secondary Outcome Measures
Name Time Method Repair cartilage structure as measured by magnetic resonance imaging (MRI) one year
Trial Locations
- Locations (31)
OrthoIndy
🇺🇸Greenwood, Indiana, United States
Shrock Clinical Research
🇺🇸Fort Lauderdale, Florida, United States
Optim Healthcare
🇺🇸Savannah, Georgia, United States
University of Washington
🇺🇸Seattle, Washington, United States
Tucson Orthopaedic Institute
🇺🇸Tucson, Arizona, United States
Grossmont Orthopedic Medical Group
🇺🇸La Mesa, California, United States
UCSF Mission Bay Orthopaedic Institute
🇺🇸San Francisco, California, United States
Southern California Orthopedic Research and Education
🇺🇸Van Nuys, California, United States
Steadman Hawkins Clinic - Denver
🇺🇸Denver, Colorado, United States
Jewett Orthopaedic Clinic
🇺🇸Orlando, Florida, United States
Colorado University Boulder
🇺🇸Boulder, Colorado, United States
St. Lukes Medical Center
🇺🇸Boise, Idaho, United States
Orthopaedic Associates
🇺🇸Portland, Maine, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Ochsner Clinic Sports Medicine
🇺🇸New Orleans, Louisiana, United States
Harvard Vanguard Medical Associates
🇺🇸West Roxbury, Massachusetts, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
TRIA Orthopaedic Center
🇺🇸Bloomington, Minnesota, United States
Hospital for Special Surgery
🇺🇸New York, New York, United States
The San Antonio Orthopaedic Group (TSAOG)
🇺🇸San Antonio, Texas, United States
Ohio State University - Department of Sports Medicine
🇺🇸Columbus, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
The Orthopedic Specialty Hospital
🇺🇸Murray, Utah, United States
Duke Sports Medicine
🇺🇸Durham, North Carolina, United States
Fowler Kennedy Sports Medicine Clinic
🇨🇦London, Ontario, Canada
Alpine Orthopedics & Sports Medicine
🇺🇸Bozeman, Montana, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Simon Fraser Orthopaedic Fund
🇨🇦New Westminster, British Columbia, Canada
Orthopaedic Specialty Institute/Newport Orthopedic Institute (OSI/NOI)
🇺🇸Orange, California, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States