A Prospective Study of NuCel® in Cervical Spine Fusion

Status Terminated

Clinical Trial Summary

Clinical Trial Description

The study is intended to demonstrate that the NuCel® allograft is effective and safe in promoting bone growth and fusion rate when used in cervical fusion in patients with one, two or three-level diseases of the cervical spine. Sixty subjects will participate in the study at a single clinical site. Participants will be at least 21 years of age. All subjects will have been established with cervical spine disease at one, two or three levels of the cervical spine that requires cervical interbody fusion per the opinion of the treating surgeon. The primary objective is to demonstrate that NuCel® is comparable to autograft bone graft in producing a successful, contiguous fusion at 6 months ±4 weeks post-operative when used in cervical fusion surgery. Success based on findings of cervical CT scan and plain radiographs. Additionally, Visual Analog Scale (VAS), Neck Disability Index (NDI) and patient satisfaction will be used as secondary outcome measures. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02381067
Study type	Interventional
Source	NuTech Medical, Inc
Contact
Status	Terminated
Phase	N/A
Start date	March 2015
Completion date	December 15, 2016

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