NCT04621799

Brief Summary

Intra-annular injections of non-autologous fibrin for moderate to severe chronic low back pain (LBP).

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
400

participants targeted

Target at P75+ for phase_2 low-back-pain

Timeline
Completed

Started Jun 2018

Typical duration for phase_2 low-back-pain

Geographic Reach
1 country

1 active site

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

June 11, 2018

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 9, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

November 9, 2020

Status Verified

November 1, 2020

Enrollment Period

2.6 years

First QC Date

November 5, 2020

Last Update Submit

November 5, 2020

Conditions

Low Back PainDisc DiseaseDisc DegenerationRadiculopathyAnnular Disc Tear

Keywords

Non-autologous fibrinMinimally InvasiveInjectionsIntervertebral discAnnulus FibrosusSciatica

Outcome Measures

Primary Outcomes (1)

  • Oswestry Disability Index (ODI)

    The Oswestry Disability Index (ODI) is a questionnaire used by clinicians and researchers to quantify disability for low back pain. Scale for the ODI is from 0 (best) - 100 (worst).

    Two Years

Secondary Outcomes (7)

  • Numeric Rating Scale (NRS)

    Two Years

  • Visual Analog Scale (VAS) for back pain

    Two Years

  • Visual Analog Scale (VAS) for leg pain

    Two Years

  • PROMIS Physical Health

    Two Years

  • PROMIS Mental Health

    Two Years

  • +2 more secondary outcomes

Study Arms (1)

Fibrin Group

EXPERIMENTAL

Experimental: Non-Autologuos Fibrin (NAF) Subjects in the NAF arm received an injection of non-autologous fibrin

Drug: Fibrin sealant

Interventions

Fibrin sealantDRUG

The intra-annular delivery of non-autologous fibrin into the annulus

Also known as: Baxter Tisseel
Fibrin Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recipient of Intra-annular fibrin injection for annular defects identified radographically and by annulogram

You may not qualify if:

  • Scoliosis greater than 20 degrees
  • Spondylolysis
  • Spondylolisthesis greater than Grade 1
  • Disc extrusion
  • Disc herniations or bulges \> 4mm causing severe stenosis
  • Prior lumbar surgery or intradiscal procedure (i.e. intradiscal electrothermal therapy, nucleoplasty)
  • Cauda equina syndrome
  • Active malignancy or tumor as source of symptoms
  • Evidence of prior lumbar vertebral body fracture or trauma
  • Foraminal stenosis at the affected levels resulting in severe thecal sac compression
  • Dynamic instability on lumbar flexion/extension radiographs
  • Positive response to diagnostic medial branch block or facet joint injection or sacroiliac joint injection
  • Known bleeding disorder
  • Known or suspected hypersensitivity or allergy to drugs or components of the fibrin sealant, including aprotinin, used in the procedure
  • Presence of ferromagnetic implants that would interfere with MRI evaluations
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Interventional Spine Specialist

Tyler, Texas, 75701, United States

RECRUITING

MeSH Terms

Conditions

Low Back PainIntervertebral Disc DegenerationRadiculopathySciatica

Interventions

Fibrin Tissue Adhesive

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal DiseasesBone DiseasesMusculoskeletal DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesSciatic NeuropathyMononeuropathiesNeuralgia

Intervention Hierarchy (Ancestors)

FibrinBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Kevin Pauza, MD

    INTERVENTIONAL SPINE SPECIALIST

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin Pauza, MD

CONTACT

239-317-3108kevinpauza@gmail.com

Carrie Wright

CONTACT

239-317-3108carrie@drkevinpauza.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A prospective evaluation of a cohort of patients with a specific characteristic over time to see if they develop a particular endpoint or outcome based on a stated hypothesis
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2020

First Posted

November 9, 2020

Study Start

June 11, 2018

Primary Completion

December 31, 2020

Study Completion

June 30, 2021

Last Updated

November 9, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)