Confirmatory Study of NeoCart in Knee Cartilage Repair
- Conditions
- Articular Cartilage Defects in the Knee Joint
- 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
- 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)
Tucson Orthopaedic Institute
🇺🇸Tucson, Arizona, United States
Grossmont Orthopedic Medical Group
🇺🇸La Mesa, California, United States
Orthopaedic Specialty Institute/Newport Orthopedic Institute (OSI/NOI)
🇺🇸Orange, California, United States
UCSF Mission Bay Orthopaedic Institute
🇺🇸San Francisco, California, United States
Southern California Orthopedic Research and Education
🇺🇸Van Nuys, California, United States
Colorado University Boulder
🇺🇸Boulder, Colorado, United States
Steadman Hawkins Clinic - Denver
🇺🇸Denver, Colorado, United States
Shrock Clinical Research
🇺🇸Fort Lauderdale, Florida, United States
Jewett Orthopaedic Clinic
🇺🇸Orlando, Florida, United States
Optim Healthcare
🇺🇸Savannah, Georgia, United States
Scroll for more (21 remaining)Tucson Orthopaedic Institute🇺🇸Tucson, Arizona, United States