Efficacy Study of NuCel® in Patients Undergoing Fusion of the Lumbar Spine

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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.

Conditions
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Intervertebral Disc Disease, Intervertebral Disc Degeneration, Spondylosis, Spondylolisthesis, Spinal Stenosis

Intervention / Treatment
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* Other: NuCel with Autograft


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: NuCel with Autograft<br>NuCel will be used with local autograft during surgical treatment of one, two or three level degenerative disease of the lumbar spine | Other: NuCel with Autograft<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spinal Fusion | CT scan will be used to evaluate fusion of one, two, or three levels | 12 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| X-ray to compare to baseline preoperative X-ray |  | 6 weeks, 3 months, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NuCel, Lumbar Spine, Degenerative Disease, Efficacy, Fusion