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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02023372
Other study ID # RD2013-11-07
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2013
Est. completion date August 16, 2019

Study information

Verified date January 2020
Source NuTech Medical, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether NuCel is effective in promoting spinal fusion in degenerative disease of the lumbar spine.


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).


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date August 16, 2019
Est. primary completion date August 16, 2019
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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.

Study Design


Intervention

Other:
NuCel with Autograft
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.

Locations

Country Name City State
United States Carolina NeuroSurgery and Spine Charlotte North Carolina

Sponsors (4)

Lead Sponsor Collaborator
NuTech Medical, Inc Atrium Health, Carolina Neurosurgery & Spine Associates, Organogenesis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Spinal Fusion CT scan will be used to evaluate fusion of one, two, or three levels 12 months
Secondary Change from baseline pain using Visual Analogue Scale (VAS) 6 weeks, 3 months, 6 months, and 12 months
Secondary Change from baseline Oswestry Disability Index (Ver. 2.1) 6 weeks, 3 months, 6 months, 12 months
Secondary X-ray to compare to baseline preoperative X-ray 6 weeks, 3 months, 6 months, 12 months
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