NOVOCART 3D Treatment Following Microfracture Failure

Status:	Recruiting
Conditions:	Orthopedic
Therapuetic Areas:	Orthopedics / Podiatry
Healthy:	No
Age Range:	18 - 66
Updated:	2/2/2019
Start Date:	November 30, 2018
End Date:	December 2021
Contact:	Jennifer Sisler, BSN, RN
Email:	jennifer.sisler@aesculapbiologics.com
Phone:	610-984-4218

Safety and Efficacy of NOVOCART 3D in the Treatment of Articular Cartilage Defects Following Failure on Microfracture

This study is prospective single arm extension study of protocol AAG-G-H-1220. It is open
only to participants of AAG-G-H-1220 randomized to the Microfracture treatment group.

This study is an extension of protocol AAG-G-H-1220 wherein patients were randomized to
either NOVOCART 3D or Microfracture treatment groups. This prospective single arm extension
study is only open to participants of AAG-G-H-1220 who were randomized to Microfracture
treatment and who failed Microfracture treatment.

Inclusion Criteria:

- participated in study AAG-G-H-1220

- identified as a microfracture failure patient

- voluntary consent to participate in the study

Exclusion Criteria:

- other cartilage repair procedures performed on target knee

- other conditions that would interfere with healing or evaluating outcomes

- lesions requiring implants larger than 9cm2

- non-compliance with requirements in study AAG-G-H-1220

We found this trial at

sites

Ohio State University

281 W. Lane Ave
Columbus, Ohio 43210

(614) 292-6446