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Fibrin for Chronic Multi-level Discogenic Low Back Pain

NCT ID: NCT04621799

Last Updated: 2020-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-11

Study Completion Date

2021-06-30

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.

Conditions

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Low Back Pain Disc Disease Disc Degeneration Radiculopathy Annular Disc Tear

Keywords

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Non-autologous fibrin Minimally Invasive Injections Intervertebral disc Annulus Fibrosus Sciatica

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fibrin Group

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

Group Type EXPERIMENTAL

Fibrin sealant

Intervention Type DRUG

The intra-annular delivery of non-autologous fibrin into the annulus

Interventions

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Fibrin sealant

The intra-annular delivery of non-autologous fibrin into the annulus

Intervention Type DRUG

Other Intervention Names

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Baxter Tisseel

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pauza, Kevin, MD

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kevin Pauza, MD

Role: PRINCIPAL_INVESTIGATOR

INTERVENTIONAL SPINE SPECIALIST

Locations

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Interventional Spine Specialist

Tyler, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kevin Pauza, MD

Role: CONTACT

Phone: 239-317-3108

Email: [email protected]

Carrie Wright

Role: CONTACT

Phone: 239-317-3108

Email: [email protected]

Facility Contacts

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Carrie Wright

Role: primary

Other Identifiers

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Regen_006-0120

Identifier Type: -

Identifier Source: org_study_id