Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® Disc Augmentation System: A Pilot Study
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 Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter Pilot Study of Resorbable Biologic Disc Augmentation for Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® Disc Augmentation System|
- Numbers and Types of Adverse Events (Only Number of Events is Reported in This Section - See Adverse Events Section for Further Detail) [ Time Frame: 104 weeks ] [ Designated as safety issue: Yes ]The primary outcome for this safety study includes the number and types of adverse events reported in the study. The data fields in this section do not allow for reporting all aspects of this outcome (i.e., the number of adverse events, as well as the types of event). These numbers were entered and are reported in the adverse event section of the Results.
- Visual Analog Scale for Low-back Pain [ Time Frame: Baseline, 26-weeks (primary endpoint), 52-weeks, 104-weeks ] [ Designated as safety issue: No ]100 mm line anchored on the left with the descriptor "No pain" (best value = 0 mm) and anchored on the right with the descriptor "Worst possible pain" (worst value = 100 mm). Lower scores indicate less pain.
- Roland-Morris Disability Questionnaire [ Time Frame: Baseline, 26-weeks (primary endpoint), 52-weeks, 104-weeks ] [ Designated as safety issue: No ]24-item questionnaire with score determined by the number of items checked by the subject. Items assess the effect of back pain on limitations of normal daily activities. Best value = 0 (least disability). Worst value = 24 (most disability). Higher number indicate greater disability.
|Study Start Date:||June 2008|
|Study Completion Date:||January 2011|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Other: Biostat® Disc Augmentation System
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).
|United States, Maryland|
|Bethesda, Maryland, United States, 20814|
|United States, Texas|
|Tyler, Texas, United States, 75701|
|United States, Washington|
|Bellingham, Washington, United States, 98226|
|Principal Investigator:||Kevin J Pauza, MD||Spine Specialists, PA|