Trials / Terminated
TerminatedNCT02381067
A Prospective Study of NuCel® in Cervical Spine Fusion
A Prospective, Efficacy Study of NuCel® in Patients Undergoing Fusion for One, Two or Three Level Degenerative Disease of the Cervical Spine
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 61 (actual)
- Sponsor
- NuTech Medical, Inc · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
The study is intended to demonstrate that the NuCel® allograft is effective and safe in promoting bone growth and fusion rate when used in cervical fusion in patients with one, two or three-level diseases of the cervical spine.
Detailed description
The study is intended to demonstrate that the NuCel® allograft is effective and safe in promoting bone growth and fusion rate when used in cervical fusion in patients with one, two or three-level diseases of the cervical spine. Sixty subjects will participate in the study at a single clinical site. Participants will be at least 21 years of age. All subjects will have been established with cervical spine disease at one, two or three levels of the cervical spine that requires cervical interbody fusion per the opinion of the treating surgeon. The primary objective is to demonstrate that NuCel® is comparable to autograft bone graft in producing a successful, contiguous fusion at 6 months ±4 weeks post-operative when used in cervical fusion surgery. Success based on findings of cervical CT scan and plain radiographs. Additionally, Visual Analog Scale (VAS), Neck Disability Index (NDI) and patient satisfaction will be used as secondary outcome measures.
Conditions
- Spondylosis
- Spinal Stenosis
- Spondylolisthesis
- Intervertebral Disc Disease
- Intervertebral Disc Degeneration
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | NuCel with Allograft Bone | NuCel is a minimally manipulated allograft product derived from amniotic membrane along with cells from amniotic fluid. Allograft bone is bone that comes another patient. NuCel and Allograft bone will be combined for this treatment. |
Timeline
- Start date
- 2015-03-01
- Primary completion
- 2016-12-01
- Completion
- 2016-12-15
- First posted
- 2015-03-06
- Last updated
- 2020-01-18
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02381067. Inclusion in this directory is not an endorsement.