Confirmatory Study of NeoCart in Knee Cartilage Repair
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.
Articular Cartilage Defects in the Knee Joint
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Comparison of NeoCart to Microfracture for the Repair of Articular Cartilage Injuries in the Knee|
- 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 ] [ Designated as safety issue: No ]
- Repair cartilage structure as measured by magnetic resonance imaging (MRI) [ Time Frame: one year ] [ Designated as safety issue: No ]
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||July 2017|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Autologous cartilagenous tissue implant
implantation of an cartilagenous tissue implant derived from the patients own cells.
Active Comparator: Microfracture
holes are created in bone at the base of the defect bed to encourage growth of tissue within the defect bed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01066702
|Contact: Kathleen Large, RN||1-855-963-6227||NeoCartContactCenter@UBC.com|
|Contact: NeoCart Website: NeoCartImplant.com|
Show 35 Study Locations
|Study Director:||Kathleen Large, RN||Histogenics Corporation|