A Prospective Study of NuCel® in Cervical Spine Fusion

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Efficacy Study of NuCel® in Patients Undergoing Fusion for One, Two or Three Level Degenerative Disease of the Cervical Spine

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

Intervention / Treatment
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* Other: NuCel with Allograft Bone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 21 years of age Have clinical and radiological evidence of degenerative disc disease, spondylosis, spinal stenosis, or spondylolisthesis at either one, two or three levels of cervical spine. In the opinion of the treating surgeon, must already be a qualified candidate for cervical fusion surgery. Be likely to return for regular follow-ups until the end of the study period. Be willing and able to provide Informed Consent for study participation. Exclusion Criteria: Neck pain due to acute trauma. Clinical, laboratory and/or radiological evidence of neck pain secondary to acute or chronic infection, malignancy, other space occupying lesions and metabolic bone demineralization diseases (e.g. osteomalacia, gout, Paget's disease etc.). Any terminal or autoimmune disease including but not limited to HIV infection, or rheumatoid arthritis. Any other concurrent medical disease or treatment that might significantly impair normal healing process as evaluated by the PI. Recent history (within past 6 months) of any chemical or alcohol dependence requiring treatment. Currently a prisoner. Currently experiencing a major mental illness (psychosis, schizophrenia, major affective disorder) which may indicate that the symptoms are psychological rather than of physical origin. Pregnancy at the time of enrollment. In order to confirm eligibility, subjects previously diagnosed with osteoporosis, osteopenia or osteomalacia, female subjects over the age of 65, post-menopausal female subjects under the age of 65 with any of the risk factors for osteoporosis, and subjects at the investigator's discretion will have DEXA scans performed prior to study entry. If DEXA is required, exclusion will be defined as a DEXA bone density measurement T score ≤ -2.5

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 Allograft Bone<br>NuCel will be used with allograft bone for the surgical treatment of one, two or three level degenerative disease of the cervical spine. | Other: NuCel with Allograft Bone<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interbody Fusion measured using CT scans and standard radiographs | Interbody fusion will be measured using CT scans and standard radiographs | 6 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, 1 year | 
| Change from baseline Neck Disability Index (NDI) |  | 6 weeks, 3 months, 6 months, 1 year | 
| Patient Satisfaction Survey |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical Fusion, NuCel, Amniotic Allograft, Prospective