NCT01011816

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

A Multicenter, Randomized, Blinded, Saline-Controlled Trial of Resorbable Biologic Disc Augmentation for Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Spinal Restoration, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The Biostat System is a combination product combining a resorbable biologic product with a delivery device system used to prepare and insert the biologic material into a lumbar intervertebral disc. Symptomatic IDD is defined as a painful disruption of the internal architecture of a lumbar intervertebral disc, which appears as fissures, cracks or tears within the internal structures of the disc. Pain arising from a lumbar disc may not only be perceived as pain located in the low back (axial pain) but also as somatic referred pain involving the posterior hips, buttocks, lateral hips, groin, or posterior thighs. The diagnosis of symptomatic IDD cannot currently be made on the basis of imaging studies, physical examination, or symptoms alone, and is best established with meticulously conducted disc provocation studies (provocation discography) that include pressure manometry and identification of an adjacent normal disc. This treatment and study are not designed for patients exhibiting other potential sources of chronic low back pain such as more advanced degenerative disc disease with significant loss of disc height (\>33%), spinal stenosis, or spondylolisthesis (see Eligibility Criteria).

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-12-01
• Completion: 2013-05-01
• First posted: 2009-11-11
• Last updated: 2014-05-16
• Results posted: 2014-05-05

Locations

20 sites across 1 country: United States