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

Primary Purpose

Intervertebral Disc Disease, Intervertebral Disc Degeneration, Spondylosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NuCel with Autograft
Sponsored by
NuTech Medical, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intervertebral Disc Disease focused on measuring NuCel, Lumbar Spine, Degenerative Disease, Efficacy, Fusion

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Carolina NeuroSurgery and Spine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

NuCel with Autograft

Arm Description

NuCel will be used with local autograft during surgical treatment of one, two or three level degenerative disease of the lumbar spine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline pain using Visual Analogue Scale (VAS)
Change from baseline Oswestry Disability Index (Ver. 2.1)
X-ray to compare to baseline preoperative X-ray

Full Information

First Posted
December 23, 2013
Last Updated
January 14, 2020
Sponsor
NuTech Medical, Inc
Collaborators
Carolina Neurosurgery & Spine Associates, Wake Forest University Health Sciences, Organogenesis
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1. Study Identification

Unique Protocol Identification Number
NCT02023372
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
August 16, 2019 (Actual)
Study Completion Date
August 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NuTech Medical, Inc
Collaborators
Carolina Neurosurgery & Spine Associates, Wake Forest University Health Sciences, Organogenesis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intervertebral Disc Disease, Intervertebral Disc Degeneration, Spondylosis, Spondylolisthesis, Spinal Stenosis
Keywords
NuCel, Lumbar Spine, Degenerative Disease, Efficacy, Fusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NuCel with Autograft
Arm Type
Other
Arm Description
NuCel will be used with local autograft during surgical treatment of one, two or three level degenerative disease of the lumbar spine
Intervention Type
Other
Intervention Name(s)
NuCel with Autograft
Intervention Description
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.
Primary Outcome Measure Information:
Title
Spinal Fusion
Description
CT scan will be used to evaluate fusion of one, two, or three levels
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change from baseline pain using Visual Analogue Scale (VAS)
Time Frame
6 weeks, 3 months, 6 months, and 12 months
Title
Change from baseline Oswestry Disability Index (Ver. 2.1)
Time Frame
6 weeks, 3 months, 6 months, 12 months
Title
X-ray to compare to baseline preoperative X-ray
Time Frame
6 weeks, 3 months, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Domagoj Coric, MD
Organizational Affiliation
Carolina Neurosurgery & Spine Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carolina NeuroSurgery and Spine
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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