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| Name | Class |
|---|---|
| Carolina Neurosurgery & Spine Associates | OTHER |
| Wake Forest University Health Sciences | OTHER |
| Organogenesis | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NuCel with Autograft | Other | NuCel will be used with local autograft during surgical treatment of one, two or three level degenerative disease of the lumbar spine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NuCel with Autograft | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Spinal Fusion | CT scan will be used to evaluate fusion of one, two, or three levels | 12 months |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Domagoj Coric, MD | Carolina Neurosurgery & Spine Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolina NeuroSurgery and Spine | Charlotte | North Carolina | 28204 | United States |
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| ID | Term |
|---|---|
| C535531 | Intervertebral disc disease |
| D055959 | Intervertebral Disc Degeneration |
| D055009 | Spondylosis |
| D013168 | Spondylolisthesis |
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
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| ID | Term |
|---|---|
| D014182 | Transplantation, Autologous |
| ID | Term |
|---|---|
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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| X-ray to compare to baseline preoperative X-ray | 6 weeks, 3 months, 6 months, 12 months |