At a glance
ClinicalIndex Comparison RecordN/ACompleted· 15 enrolled
Drug / intervention
Biostat® Disc Augmentation Systembiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter Pilot Study of Resorbable Biologic Disc Augmentation for Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® Disc Augmentation System
In Brief
A clinical study evaluating Biostat® Disc Augmentation System for Low Back Pain. Completed, enrolled 15 participants across 3 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2008
First PostedJun 2008
Primary CompletionFeb 2009
Study CompletionJan 2011
TodayJul 2026
First PostedJun 9, 2008
Enrollment StartJun 1, 2008
Primary CompletionFeb 1, 2009
Study CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.1 years ago
Interventions
Biostat® Disc Augmentation Systembiological
Delivery of Biostat BIOLOGX® Fibrin Sealant with the Biostat Delivery Device