Intervertebral Disc Degeneration, Intervertebral Disc Disease, Spinal Stenosis, Spondylolisthesis, Spondylosis
Conditions
Keywords
NuCel, Lumbar Spine, Degenerative Disease, Efficacy, Fusion
Brief summary
The purpose of this study is to determine whether NuCel is effective in promoting spinal fusion in degenerative disease of the lumbar spine.
Detailed description
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).
Interventions
OTHERNuCel with Autograft
NuCel is a minimally manipulated allograft product derived from amniotic membrane along with cells from amniotic fluid. Local autograft is bone that comes from the patient's own vertebrae and surrounding bony structures.
Sponsors
Carolina Neurosurgery & Spine Associates
Wake Forest University Health Sciences
Organogenesis
NuTech Medical, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be diagnosed with degenerative disease of lumbar spine
Exclusion criteria
* Back pain due to injury * Back pain that is caused by infection, cancer, lesions(growths) or bone disease such as osteoporosis * Any terminal (will not recover from the disease) or autoimmune disease including but not limited to HIV infection, or rheumatoid arthritis * Any other medical condition that might affect normal healing * Less than 21 years of age * More than three levels of fusion needed * Recent history (within past 6 months) of any chemical or alcohol dependence * Morbid obesity (Body Mass Index of more than 40) * Currently a prisoner * Currently experiencing a major mental illness * Pregnancy at the time of enrollment * Previously diagnosed with diseases of the bone such as osteoporosis, osteopenia or osteomalacia (softening of the bones). Patients with any of the risk factors for osteoporosis may have DEXA scans performed prior to study entry.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spinal Fusion | 12 months | CT scan will be used to evaluate fusion of one, two, or three levels |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline pain using Visual Analogue Scale (VAS) | 6 weeks, 3 months, 6 months, and 12 months |
| Change from baseline Oswestry Disability Index (Ver. 2.1) | 6 weeks, 3 months, 6 months, 12 months |
| X-ray to compare to baseline preoperative X-ray | 6 weeks, 3 months, 6 months, 12 months |
Countries
United States
Outcome results
None listed