NCT02381067

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2016

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

1.8 years

First QC Date

March 2, 2015

Last Update Submit

January 14, 2020

Conditions

SpondylosisSpinal StenosisSpondylolisthesisIntervertebral Disc DiseaseIntervertebral Disc Degeneration

Keywords

Cervical FusionNuCelAmniotic AllograftProspective

Outcome Measures

Primary Outcomes (1)

  • Interbody Fusion measured using CT scans and standard radiographs

    Interbody fusion will be measured using CT scans and standard radiographs

    6 months

Secondary Outcomes (3)

  • 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

  • Patient Satisfaction Survey

    1 year

Study Arms (1)

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

NuCel with Allograft BoneOTHER

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.

NuCel with Allograft Bone

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wellstar Hospital

Marietta, Georgia, 30060, United States

Location

MeSH Terms

Conditions

SpondylosisSpinal StenosisSpondylolisthesisIntervertebral disc diseaseIntervertebral Disc DegenerationKlippel-Feil Syndrome

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesSpondylolysisDysostosesBone Diseases, DevelopmentalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Franklin Lin, M.D.

    Wellstar Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2015

First Posted

March 6, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 15, 2016

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)