Clinical trial NCT04621799: Fibrin for Chronic Multi-level Discogenic Low Back Pain
Official title: A Prospective Registry Study Evaluating the Safety and Efficacy of Fibrin for Chronic Multi-level Discogenic Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Low Back Pain
Disc Disease
Disc Degeneration
Radiculopathy
Annular Disc Tear
Keywords: Non-autologous fibrin
Minimally Invasive
Injections
Intervertebral disc
Annulus Fibrosus
Sciatica
Lead sponsor: Pauza, Kevin, MD
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility 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)

Primary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: Two Years
Secondary outcomes:
measure: Numeric Rating Scale (NRS)
timeFrame: Two Years
measure: Visual Analog Scale (VAS) for back pain
timeFrame: Two Years
measure: Visual Analog Scale (VAS) for leg pain
timeFrame: Two Years
measure: PROMIS Physical Health
timeFrame: Two Years
measure: PROMIS Mental Health
timeFrame: Two Years
measure: North American Spine Society (NASS) for patient satisfaction
timeFrame: Two Years
measure: EURO Quality of Life (EuroQol)
timeFrame: Two Years
Other outcomes:
Locations:
city: Tyler
country: United States
facility: Interventional Spine Specialist
state: Texas
Study officials:
affiliation: INTERVENTIONAL SPINE SPECIALIST
name: Kevin Pauza, MD
role: PRINCIPAL_INVESTIGATOR
References: