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Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System

NCT01011816 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2014-05-16

Study results available
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Summary

The purpose of this investigation is to establish the safety and efficacy of the Biostat System when used for treatment of chronic low back (lumbar) pain due to symptomatic internal disc disruptions (IDD) by comparing safety and efficacy outcome measures between one group receiving BIOSTAT BIOLOGX® Fibrin Sealant through the Biostat® Delivery Device and another group receiving a preservative-free normal saline control delivered with the Biostat Delivery Device.

Conditions

  • Back Pain
  • Chronic Low Back Pain
  • Internal Disc Disruption
  • Degenerative Disc Disease

Interventions

BIOLOGICAL

BIOSTAT BIOLOGX

One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device

DRUG

Saline

One injection of up to 4 mL of saline using the Biostat Delivery Device

Sponsors & Collaborators

  • Spinal Restoration, Inc.

    lead INDUSTRY

Principal Investigators

  • Kevin J Pauza, MD · Spine Specialists PA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-12-31
Completion
2013-05-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01011816 on ClinicalTrials.gov