A Phase 3 Prospective, Randomized, Partially Blinded Multi-Center Study to Measure the Safety and Efficacy of NOVOCART® 3D, Compared to Microfracture in the Treatment of Articular Cartilage Defects
Eligibility
Inclusion Criteria:
The inclusion criteria for the study are patients between the ages of 18 and 65 who have symptomatic knee pain indicative of articular cartilage defects; intact ligaments or sufficiently repaired ligaments; full ROM; normally functioning contralateral knee; KOOS Pain: 18/36; KOOS ADL: 25/68.
Exclusion Criteria:
The exclusion criteria for the study are patients who are obese (BMI>40); surgery on contralateral knee within 6 months or injection 1 month of surgery; prior cartilage treatment in target knee; pregnancy; rheumatological disease; clinically significant OA; <3mm of joint space on X-Ray; history of DVT; taking immune modulating drugs or anti-coagulants; history of drug/alcohol abuse; workers compensation.
Contact
- iw@drivanwong.com, 902-472-2114, Ivan.Wong@nshealth.ca
PI
Dr. Ivan Wong
Description
This randomized, controlled trial is comparing microfracture to Novocart implant for treating chondral defects in the knee (1:2 randomization). Microfracture will be one surgery while Novocart will be two surgeries. The primary outcome will be evaluated by Knee Osteoarthritis Outcomes Survey (KOOS) and the secondary outcome is to evaluate the safety and efficacy of each treatment.
Sample size = 43