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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
245
implantation of an cartilagenous tissue implant derived from the patients own cells.
holes are created in bone at the base of the defect bed to encourage growth of tissue within the defect bed.
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)
Time frame: one year
Repair cartilage structure as measured by magnetic resonance imaging (MRI)
Time frame: one year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 21 more locations