Clinical trial NCT02023372: Efficacy Study of NuCel® in Patients Undergoing Fusion of the Lumbar Spine
Official title: NuTech NuCel®: A Prospective, Efficacy Study of NuCel® in Patients Undergoing Fusion for One, Two or Three Level Degenerative Disease of the Lumbar Spine.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intervertebral Disc Disease
Intervertebral Disc Degeneration
Spondylosis
Spondylolisthesis
Spinal Stenosis
Keywords: NuCel
Lumbar Spine
Degenerative Disease
Efficacy
Fusion
Lead sponsor: NuTech Medical, Inc
Sponsor class: INDUSTRY
Collaborators: name: Carolina Neurosurgery & Spine Associates
name: Wake Forest University Health Sciences
name: Organogenesis
First posted: 2013-12-30
Enrollment: 57
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Spinal Fusion
timeFrame: 12 months
Secondary outcomes:
measure: Change from baseline pain using Visual Analogue Scale (VAS)
timeFrame: 6 weeks, 3 months, 6 months, and 12 months
measure: Change from baseline Oswestry Disability Index (Ver. 2.1)
timeFrame: 6 weeks, 3 months, 6 months, 12 months
measure: X-ray to compare to baseline preoperative X-ray
timeFrame: 6 weeks, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolina NeuroSurgery and Spine
state: North Carolina
Study officials:
affiliation: Carolina Neurosurgery & Spine Associates
name: Domagoj Coric, MD
role: PRINCIPAL_INVESTIGATOR
References: