Fibrin for Chronic Multi-level Discogenic Low Back Pain

November 5, 2020 updated by: Pauza, Kevin, MD

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Tyler, Texas, United States, 75701
        • Recruiting
        • Interventional Spine Specialist
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Fibrin Group
Experimental: Non-Autologuos Fibrin (NAF) Subjects in the NAF arm received an injection of non-autologous fibrin
Drug: Fibrin sealant
The intra-annular delivery of non-autologous fibrin into the annulus
Other Names:
  • Baxter Tisseel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index (ODI)
Time Frame: Two Years
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)
Time Frame: Two Years
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
Time Frame: Two Years
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
Time Frame: Two Years
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
Time Frame: Two Years
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
Time Frame: Two Years
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
Time Frame: Two Years
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)
Time Frame: Two Years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pauza, Kevin, MD

Investigators

  • Principal Investigator: Kevin Pauza, MD, Interventional Spine Specialist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 11, 2018

Primary Completion (ANTICIPATED)

December 31, 2020

Study Completion (ANTICIPATED)

June 30, 2021

Study Registration Dates

First Submitted

November 5, 2020

First Submitted That Met QC Criteria

November 5, 2020

First Posted (ACTUAL)

November 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 9, 2020

Last Update Submitted That Met QC Criteria

November 5, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Regen_006-0120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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