Fibrin for Chronic Multi-level Discogenic Low Back Pain

• Status: Recruiting
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pauza, Kevin, MD
• Treatments: Fibrin Tissue Adhesive

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)