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Fibrin for Chronic Multi-level Discogenic Low Back Pain

Primary Purpose

Low Back Pain, Disc Disease, Disc Degeneration

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fibrin sealant
Sponsored by
Pauza, Kevin, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Non-autologous fibrin, Minimally Invasive, Injections, Intervertebral disc, Annulus Fibrosus, Sciatica

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

  • Interventional Spine SpecialistRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fibrin Group

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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
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)
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).
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).
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).

Full Information

First Posted
November 5, 2020
Last Updated
November 5, 2020
Sponsor
Pauza, Kevin, MD
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1. Study Identification

Unique Protocol Identification Number
NCT04621799
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 11, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pauza, Kevin, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Disc Disease, Disc Degeneration, Radiculopathy, Annular Disc Tear
Keywords
Non-autologous fibrin, Minimally Invasive, Injections, Intervertebral disc, Annulus Fibrosus, Sciatica

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fibrin Group
Arm Type
Experimental
Arm Description
Experimental: Non-Autologuos Fibrin (NAF) Subjects in the NAF arm received an injection of non-autologous fibrin
Intervention Type
Drug
Intervention Name(s)
Fibrin sealant
Other Intervention Name(s)
Baxter Tisseel
Intervention Description
The intra-annular delivery of non-autologous fibrin into the annulus
Primary Outcome Measure Information:
Title
Oswestry Disability Index (ODI)
Description
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).
Time Frame
Two Years
Secondary Outcome Measure Information:
Title
Numeric Rating Scale (NRS)
Description
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).
Time Frame
Two Years
Title
Visual Analog Scale (VAS) for back pain
Description
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).
Time Frame
Two Years
Title
Visual Analog Scale (VAS) for leg pain
Description
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
Time Frame
Two Years
Title
PROMIS Physical Health
Description
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)
Time Frame
Two Years
Title
PROMIS Mental Health
Description
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).
Time Frame
Two Years
Title
North American Spine Society (NASS) for patient satisfaction
Description
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).
Time Frame
Two Years
Title
EURO Quality of Life (EuroQol)
Description
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).
Time Frame
Two Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Pauza, MD
Phone
239-317-3108
Email
kevinpauza@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Carrie Wright
Phone
239-317-3108
Email
carrie@drkevinpauza.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Pauza, MD
Organizational Affiliation
INTERVENTIONAL SPINE SPECIALIST
Official's Role
Principal Investigator
Facility Information:
Facility Name
Interventional Spine Specialist
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carrie Wright
Phone
903-941-9357
Email
carrie@drkevinpauza.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Fibrin for Chronic Multi-level Discogenic Low Back Pain

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