Recruiting
Phase 2
Phase 3

Fibrin

Sponsor:

Pauza, Kevin, MD

Code:

NCT04621799

Conditions

Low Back Pain

Disc Disease

Disc Degeneration

Radiculopathy

Annular Disc Tear

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Fibrin sealant

Study Details

Brief summary:

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

Conditions

Low Back Pain

Disc Disease

Disc Degeneration

Radiculopathy

Annular Disc Tear

Study ID

NCT04621799

Start date

Jun 11, 2018

Status verified date

Nov, 2020

Completion date

Jun 30, 2021

Anticipated

Primary completion date

Dec 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • Active or pending workers' compensation claims or other litigation related to the condition.
  • Pregnant or plans to become pregnant over the course of study participation (2 years)

Study Design

Enrollment

400 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fibrin Group

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

Interventions

Fibrin sealant

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

Primary outcome measure

  • Oswestry Disability Index (ODI) [ Time Frame: Two Years ]

Central Contacts and Locations

Central contacts

Kevin Pauza, MD

239-317-3108kevinpauza@gmail.com

Carrie Wright

239-317-3108carrie@drkevinpauza.com

Locations

Interventional Spine Specialist

Recruiting

Tyler, Texas, United States, 75701

Contacts

Carrie Wright

903-941-9357carrie@drkevinpauza.com

More Information

Sponsor

Pauza, Kevin, MD

Last update posted

Nov 9, 2020

Last verified

Nov, 2020

Keywords

  • Non-autologous fibrin
  • Minimally Invasive
  • Injections
  • Intervertebral disc
  • Annulus Fibrosus
  • Sciatica

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Pauza, Kevin, MD on 2020-11-09.