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

N/ACompletedNCT02023372

NuTech Medical, Inc57 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Intervertebral Disc Disease Intervertebral Disc Degeneration Spondylosis Spondylolisthesis Spinal Stenosis

Interventions

NuCel with AutograftOTHER

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.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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.

Locations (1)

Carolina NeuroSurgery and Spine

Charlotte, North Carolina, United States

Outcomes

Primary Outcomes

Spinal Fusion

CT scan will be used to evaluate fusion of one, two, or three levels

Time frame: 12 months

Secondary Outcomes

Change from baseline pain using Visual Analogue Scale (VAS)

Time frame: 6 weeks, 3 months, 6 months, and 12 months

Change from baseline Oswestry Disability Index (Ver. 2.1)

Time frame: 6 weeks, 3 months, 6 months, 12 months

X-ray to compare to baseline preoperative X-ray

Time frame: 6 weeks, 3 months, 6 months, 12 months

Data from ClinicalTrials.gov

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