NCT00693784

Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® Disc Augmentation System: A Pilot Study

A Multicenter Pilot Study of Resorbable Biologic Disc Augmentation for Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® Disc Augmentation System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Spinal Restoration, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety of the Biostat Disc Augmentation System for the treatment of chronic low-back (lumbar) pain due to symptomatic internal disc disruptions (IDD) and to obtain preliminary efficacy information.

Detailed description

The Biostat Disc Augmentation 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, buttock, 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 must be 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

• Low Back Pain

Interventions

Type	Name	Description
BIOLOGICAL	Biostat® Disc Augmentation System	Delivery of Biostat BIOLOGX® Fibrin Sealant with the Biostat Delivery Device

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-02-01
• Completion: 2011-01-01
• First posted: 2008-06-09
• Last updated: 2015-06-22
• Results posted: 2010-04-29

Locations

3 sites across 1 country: United States