NCT02808234

Brief Summary

The study is a prospective non-randomized multi-center feasibility clinical trial to establish the safety and efficacy of the Nucel® allograft tissue for use in lumbar interbody fusion procedures.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

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

December 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 21, 2016

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

May 26, 2021

Status Verified

May 1, 2021

Enrollment Period

7 years

First QC Date

June 7, 2016

Last Update Submit

May 21, 2021

Conditions

Degenerative Disc DiseaseSpondylolisthesisSpondylosis

Outcome Measures

Primary Outcomes (1)

  • Fusion rate using non-contrast CT of the lumbar spine

    Fusion will be assessed 2 years by independent radiologist using alpha-numeric grading scale to quantify bone growth and supplemental fixation quality

    2 years

Other Outcomes (4)

  • Neurologic Exam

    2 years

  • Visual Analogue Scale

    2 years

  • Oswestry Low Back Pain Disability Index

    2 years

  • +1 more other outcomes

Study Arms (1)

Nucel treatment group

OTHER

One or two level lumbar interbody fusion surgery with Nucel

Procedure: One or two level lumbar interbody fusion surgeryOther: Nucel

Interventions

One or two level lumbar interbody fusion surgeryPROCEDURE

One or two level lumbar interbody fusion surgery with allograft derived from human amnion and amniotic fluid.

Nucel treatment group
NucelOTHER

Allograft derived from human amnion and amniotic fluid

Nucel treatment group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be between 18 and 75 years of age
  • Have clinical and/or radiological evidence of stenosis, spondylolisthesis, spondylosis or degenerative disc disease, or at either one or two levels of lumbar spine.
  • In the opinion of the treating surgeon, must already be a qualified candidate for interbody lumbar fusion surgery with supplemental fixation.
  • 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:

  • Previous lumbar spine fusion surgery at operative level.
  • Back pain due to acute trauma.
  • Clinical, laboratory and/or radiological evidence of back 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.)
  • No chronic steroid or chronic prescription NSAID use within three (3) months prior to surgery.
  • Any active malignancy, infectious process, or documented chronic autoimmune disease.
  • Any other concurrent medical disease or treatment that might impair normal healing process.
  • Recent history (within past 6 months) of any chemical or alcohol dependence.
  • Morbid obesity (BMI \> 40).
  • 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 or planned pregnancy, which would interfere with follow-up imaging.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Florida Orthopaedic Insitute

Tampa, Florida, 33609, United States

Location

Spine Institute of Louisiana

Shreveport, Louisiana, 71101, United States

Location

Carolina Neurosurgery & Spine

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Intervertebral Disc DegenerationSpondylolisthesisSpondylosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesSpondylolysis

Study Officials

  • Pierce Nunley, MD

    Spine Institute of Louisiana

    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

June 7, 2016

First Posted

June 21, 2016

Study Start

December 1, 2015

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

May 26, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

US(3)