Fibrin for Chronic Multi-level Discogenic Low Back Pain

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

Detailed Description
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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.

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

Conditions
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Low Back Pain, Disc Disease, Disc Degeneration, Radiculopathy, Annular Disc Tear

Intervention / Treatment
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* Drug: Fibrin sealant


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fibrin Group<br>Experimental: Non-Autologuos Fibrin (NAF) Subjects in the NAF arm received an injection of non-autologous fibrin | Drug: Fibrin sealant<br>* The intra-annular delivery of non-autologous fibrin into the annulus<br>* Other names: Baxter Tisseel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index (ODI) | The Oswestry Disability Index (ODI) is a questionnaire used by clinicians and researchers to quantify disability for low back pain. Scale for the ODI is from 0 (best) - 100 (worst). | Two Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Rating Scale (NRS) | The NRS consists of a numeric version of the visual analog scale. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible. Scale for NRS is from 0 (best) - 10 (worst). | Two Years | 
| Visual Analog Scale (VAS) for back pain | When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. Scale for VAS for back pain is from 0 (best) - 10 (worst). | Two Years | 
| Visual Analog Scale (VAS) for leg pain | When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. Scale for VAS for leg pain is from 0 (best) - 10 (wors | Two Years | 
| PROMIS Physical Health | The PROMIS Global-10 is a publicly available global health assessment tool that allows measurements of symptoms, functioning, and healthcare-related quality of life (HRQoL) for a wide variety of chronic diseases and conditions. Scale for PROMIS Physical Health is from 16.2 (worst) - 67.7 (best) | Two Years | 
| PROMIS Mental Health | The PROMIS Global-10 is a publicly available global health assessment tool that allows measurements of symptoms, functioning, and healthcare-related quality of life (HRQoL) for a wide variety of chronic diseases and conditions. Scale for PROMIS Mental Health is from 21.2 (worst) - 67.6 (best). | Two Years | 
| North American Spine Society (NASS) for patient satisfaction | The North American Spine Society (NASS) developed an outcome assessment instrument to measure diverse dimensions of the impact of lumbar spine problems. Scale range is from 1 to 4 (best to worst). | Two Years | 
| EURO Quality of Life (EuroQol) | EuroQol is an instrument which evaluates the generic quality of life developed in Europe and widely used. Scale is from 0.33 (worst - 0.88 (best). | Two Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Injections, Non-autologous fibrin, Minimally Invasive, Intervertebral disc, Annulus Fibrosus, Sciatica