Trial | NCT04621799  Report issue

Title

Fibrin for Chronic Multi-level Discogenic Low Back Pain
A Prospective Registry Study Evaluating the Safety and Efficacy of Fibrin for Chronic Multi-level Discogenic Low Back Pain

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    400
Intra-annular injections of non-autologous fibrin for moderate to severe chronic low back pain (LBP).
The purpose of this study is to analyze data available in the PIs Regenerative Orthobiologics Registry (ROR) and corresponding patient charts that will either support or refute the efficacy of Intra-annular fibrin as treatment for moderate to severe low back pain. Additionally, we seek to retrospectively identify possible predisposing factors that are correlated with positive outcomes with respect to patient-reported pain and function.
Study Started
Jun 11
2018
Primary Completion
Dec 31
2020
Anticipated
Study Completion
Jun 30
2021
Anticipated
Last Update
Nov 09
2020

Drug Fibrin sealant

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

  • Other names: Baxter Tisseel

Fibrin Group Experimental

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

Criteria 

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)
No Results Posted