Back to resultsA Prospective Study of NuCel® in Cervical Spine Fusion
Primary Purpose
Spondylosis, Spinal Stenosis, Spondylolisthesis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NuCel with Allograft Bone
Sponsored by
About this trial
This is an interventional treatment trial for Spondylosis focused on measuring Cervical Fusion, NuCel, Amniotic Allograft, Prospective
Eligibility Criteria
Inclusion Criteria:
- Be at least 21 years of age
- Have clinical and radiological evidence of degenerative disc disease, spondylosis, spinal stenosis, or spondylolisthesis at either one, two or three levels of cervical spine.
- In the opinion of the treating surgeon, must already be a qualified candidate for cervical fusion surgery.
- Be likely to return for regular follow-ups until the end of the study period.
- Be willing and able to provide Informed Consent for study participation.
Exclusion Criteria:
- Neck pain due to acute trauma.
- Clinical, laboratory and/or radiological evidence of neck pain secondary to acute or chronic infection, malignancy, other space occupying lesions and metabolic bone demineralization diseases (e.g. osteomalacia, gout, Paget's disease etc.).
- Any terminal or autoimmune disease including but not limited to HIV infection, or rheumatoid arthritis.
- Any other concurrent medical disease or treatment that might significantly impair normal healing process as evaluated by the PI.
- Recent history (within past 6 months) of any chemical or alcohol dependence requiring treatment.
- Currently a prisoner.
- Currently experiencing a major mental illness (psychosis, schizophrenia, major affective disorder) which may indicate that the symptoms are psychological rather than of physical origin.
- Pregnancy at the time of enrollment.
- In order to confirm eligibility, subjects previously diagnosed with osteoporosis, osteopenia or osteomalacia, female subjects over the age of 65, post-menopausal female subjects under the age of 65 with any of the risk factors for osteoporosis, and subjects at the investigator's discretion will have DEXA scans performed prior to study entry. If DEXA is required, exclusion will be defined as a DEXA bone density measurement T score ≤ -2.5
Sites / Locations
- Wellstar Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
NuCel with Allograft Bone
Arm Description
NuCel will be used with allograft bone for the surgical treatment of one, two or three level degenerative disease of the cervical spine.
Outcomes
Primary Outcome Measures
Interbody Fusion measured using CT scans and standard radiographs
Interbody fusion will be measured using CT scans and standard radiographs
Secondary Outcome Measures
Change from baseline pain using Visual Analogue Scale (VAS)
Change from baseline Neck Disability Index (NDI)
Patient Satisfaction Survey
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02381067
Brief Title
A Prospective Study of NuCel® in Cervical Spine Fusion
Official Title
A Prospective, Efficacy Study of NuCel® in Patients Undergoing Fusion for One, Two or Three Level Degenerative Disease of the Cervical Spine
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Departure of PI from the study facility
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 1, 2016 (Actual)
Study Completion Date
December 15, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NuTech Medical, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondylosis, Spinal Stenosis, Spondylolisthesis, Intervertebral Disc Disease, Intervertebral Disc Degeneration
Keywords
Cervical Fusion, NuCel, Amniotic Allograft, Prospective
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NuCel with Allograft Bone
Arm Type
Other
Arm Description
NuCel will be used with allograft bone for the surgical treatment of one, two or three level degenerative disease of the cervical spine.
Intervention Type
Other
Intervention Name(s)
NuCel with Allograft Bone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Interbody Fusion measured using CT scans and standard radiographs
Description
Interbody fusion will be measured using CT scans and standard radiographs
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from baseline pain using Visual Analogue Scale (VAS)
Time Frame
6 weeks, 3 months, 6 months, 1 year
Title
Change from baseline Neck Disability Index (NDI)
Time Frame
6 weeks, 3 months, 6 months, 1 year
Title
Patient Satisfaction Survey
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be at least 21 years of age
Have clinical and radiological evidence of degenerative disc disease, spondylosis, spinal stenosis, or spondylolisthesis at either one, two or three levels of cervical spine.
In the opinion of the treating surgeon, must already be a qualified candidate for cervical fusion surgery.
Be likely to return for regular follow-ups until the end of the study period.
Be willing and able to provide Informed Consent for study participation.
Exclusion Criteria:
Neck pain due to acute trauma.
Clinical, laboratory and/or radiological evidence of neck pain secondary to acute or chronic infection, malignancy, other space occupying lesions and metabolic bone demineralization diseases (e.g. osteomalacia, gout, Paget's disease etc.).
Any terminal or autoimmune disease including but not limited to HIV infection, or rheumatoid arthritis.
Any other concurrent medical disease or treatment that might significantly impair normal healing process as evaluated by the PI.
Recent history (within past 6 months) of any chemical or alcohol dependence requiring treatment.
Currently a prisoner.
Currently experiencing a major mental illness (psychosis, schizophrenia, major affective disorder) which may indicate that the symptoms are psychological rather than of physical origin.
Pregnancy at the time of enrollment.
In order to confirm eligibility, subjects previously diagnosed with osteoporosis, osteopenia or osteomalacia, female subjects over the age of 65, post-menopausal female subjects under the age of 65 with any of the risk factors for osteoporosis, and subjects at the investigator's discretion will have DEXA scans performed prior to study entry. If DEXA is required, exclusion will be defined as a DEXA bone density measurement T score ≤ -2.5
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franklin Lin, M.D.
Organizational Affiliation
Wellstar Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wellstar Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Prospective Study of NuCel® in Cervical Spine Fusion
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