Novocart vs Microfracture for Cartilage Damage in the Knee - Clinical Trial

What is the Purpose of this Study?

If you choose to join this study, you will:
- Be randomized (like flipping a coin) into Group 1 or Group 2
-- Group 1 will have an implant made from your own knee cartilage and placed in your knee to fix the damage
-- Group 2 will have the injured cartilage removed and have a clot made in your knee to fix the cartilage (standard of care)
- Complete 13 follow up visits over 5 years
- Complete questionnaires about your knee and health

What is the Condition Being Studied?

Cartilage Damage in the Knee

Who Can Participate in the Study?

Adults 18-65
Have cartilage damage like 'pothole' in the knee (osteochondral defect (OCD))
Have had poor results from past treatment
No significant arthritis

Age Group
Adults

What is Involved?

We are doing this study to show that making implants from cartilage cells is better than removing the cartilage and making a clot to treat knee cartilage with a 'pothole' in it.

Study Details

Full Title
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
Principal Investigator
Orthopaedic Surgeon
Protocol Number
IRB: PRO00102328
NCT: NCT01957722
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698