A Prospective Study of NuCel® in Cervical Spine Fusion | NCT02381067

Studies
A Prospective Study of NuCel® in Cervical Spine Fusion

NCT02381067

Sponsor

NuTech Medical, Inc

Status

Terminated

Last Update Posted

Jan 18, 2020Actual

Enrollment

61Actual

Phase

Not Applicable

Conditions

Spondylosis
Spinal Stenosis
Spondylolisthesis
Intervertebral Disc Disease
Intervertebral Disc Degeneration

Interventions

NuCel with Allograft Bone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Departure of PI from the study facility

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Dec 1, 2016Actual

Completion Date

Dec 15, 2016Actual

First Submitted Date

Mar 2, 2015

First Submission Date that Met QC Criteria

Mar 5, 2015

First Posted Date

Mar 6, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2020

Last Update Posted Date

Jan 18, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NuCel with Allograft Bone	Other	NuCel will be used with allograft bone for the surgical treatment of one, two or three level degenerative disease of the cervical spine.	Other: NuCel with Allograft Bone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NuCel with Allograft Bone	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Interbody Fusion measured using CT scans and standard radiographs	Interbody fusion will be measured using CT scans and standard radiographs	6 months

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline pain using Visual Analogue Scale (VAS)		6 weeks, 3 months, 6 months, 1 year
Change from baseline Neck Disability Index (NDI)		6 weeks, 3 months, 6 months, 1 year

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Franklin Lin, M.D.	Wellstar Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Wellstar Hospital		Marietta	Georgia	30060	United States

Condition Browse Module

MeSH Terms

ID	Term
D055009	Spondylosis
D013130	Spinal Stenosis
D013168	Spondylolisthesis
C535531	Intervertebral disc disease
D055959	Intervertebral Disc Degeneration
D007714	Klippel-Feil Syndrome

Ancestor Terms

ID	Term
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D013169	Spondylolysis

Browse Leaves

Not provided

Browse Branches

Not provided