Clinical Trial: NOVOCART®3D for Treatment of Articular Cartilage of the Knee

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 3, Prospective, Randomized, Partially Blinded Multi-Center Study to Measure the Safety and Efficacy of NOVOCART 3D Compared ot Microfracture in the Treatment of Articular Cartilage Defects

Brief Summary: This study is to NOVOCART 3D relative to Microfracture for the treatment of knee cartilage defects. Efficacy will be evaluated by both pain and function. Safety will also be evaluated.

Detailed Summary: Subjects with articular knee defects will be randomized to receive either Microfracture or NOVOCART 3D. Subjects will be followed for five years in total and will be evaluated for safety and efficacy.
Sponsor: Aesculap Biologics, LLC

Current Primary Outcome:

• Pain [ Time Frame: 24 months post treatment ]
  As measured by change in score from Baseline in KOOS score
• Function [ Time Frame: 24 months post treatment ]
  As measured by change in score from Baseline in KOOS score

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Aesculap Biologics, LLC

Dates:
Date Received: September 17, 2013
Date Started: January 2014
Date Completion: August 2021
Last Updated: November 23, 2016
Last Verified: November 2016