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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
NuCel is a minimally manipulated allograft product derived from amniotic membrane along with cells from amniotic fluid. Allograft bone is bone that comes another patient. NuCel and Allograft bone will be combined for this treatment.
Wellstar Hospital
Marietta, Georgia, United States
Interbody Fusion measured using CT scans and standard radiographs
Interbody fusion will be measured using CT scans and standard radiographs
Time frame: 6 months
Change from baseline pain using Visual Analogue Scale (VAS)
Time frame: 6 weeks, 3 months, 6 months, 1 year
Change from baseline Neck Disability Index (NDI)
Time frame: 6 weeks, 3 months, 6 months, 1 year
Patient Satisfaction Survey
Time frame: 1 year
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