Trials / Completed
CompletedNCT02023372
Efficacy Study of NuCel® in Patients Undergoing Fusion of the Lumbar Spine
NuTech NuCel®: A Prospective, Efficacy Study of NuCel® in Patients Undergoing Fusion for One, Two or Three Level Degenerative Disease of the Lumbar Spine.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 57 (actual)
- Sponsor
- NuTech Medical, Inc · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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).
Conditions
- Intervertebral Disc Disease
- Intervertebral Disc Degeneration
- Spondylosis
- Spondylolisthesis
- Spinal Stenosis
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2013-12-01
- Primary completion
- 2019-08-16
- Completion
- 2019-08-16
- First posted
- 2013-12-30
- Last updated
- 2020-01-18
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02023372. Inclusion in this directory is not an endorsement.