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NuTech NuCel®: A Prospective, Efficacy Study of NuCel® in Patients Undergoing Fusion for One, Two or Three Level Degenerative Disease of the Lumbar Spine.
The purpose of this study is to determine whether NuCel is effective in promoting spinal fusion in degenerative disease of the lumbar spine.
The study is a prospective, single center clinical trial to establish the efficacy of NuCel, a minimally manipulated allograft tissue, for use in lumbar interbody and intertransverse fusion procedures. Subjects will undergo standard interbody fusion surgery as per the signed informed consent with NuCel and autograft bone. Patients will be evaluated postoperatively at 6 weeks, 3 months, 6 months, 1 year, and 2 years (if required).
Age
21 - No limit years
Sex
ALL
Healthy Volunteers
No
Carolina NeuroSurgery and Spine
Charlotte, North Carolina, United States
Start Date
December 1, 2013
Primary Completion Date
August 16, 2019
Completion Date
August 16, 2019
Last Updated
January 18, 2020
57
ACTUAL participants
NuCel with Autograft
OTHER
Lead Sponsor
NuTech Medical, Inc
Collaborators
Data Source & Attribution
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