Fibrin for Chronic Multi-level Discogenic Low Back Pain

Pauza, Kevin, MD

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Radiculopathy; Annular Disc Tear; Disc Degeneration; Disc Disease; Low Back Pain

Treatments: Drug: Fibrin sealant

Study type: Interventional

Funder types: Other

Identifiers

NCT04621799

Regen_006-0120

Details and patient eligibility

About

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

Full description

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

Fibrin Group

Experimental group

Description:

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

Treatment:

Drug: Fibrin sealant