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

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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
2
sites
North Logan, Utah 84341
Principal Investigator: Brad Larson, MD
Phone: 435-774-8512
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: David Flanigan, MD
Phone: 614-293-2410
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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