Articular Cartilage Defects in the Knee Joint
Conditions
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.
Interventions
BIOLOGICALNeoCart
implantation of an cartilagenous tissue implant derived from the patients own cells.
PROCEDUREMicrofracture
holes are created in bone at the base of the defect bed to encourage growth of tissue within the defect bed.
Sponsors
Histogenics Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
* greater than 18 years old * symptomatic articular cartilage lesion of the femur and/or trochlea
Exclusion criteria
* prior surgical intervention other than debridement * arthritis * clinically significant or symptomatic vascular or neurologic disorder of the lower extremities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Repair cartilage structure as measured by magnetic resonance imaging (MRI) | one year |
Countries
Canada, United States
Outcome results
None listed