Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System
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|ClinicalTrials.gov Identifier: NCT01011816|
Recruitment Status : Terminated (Stopped prior to last subject's last extended follow-up visit (78 weeks) due to lack of efficacy at the primary study endpoint (26 weeks))
First Posted : November 11, 2009
Results First Posted : May 5, 2014
Last Update Posted : May 16, 2014
|Condition or disease||Intervention/treatment||Phase|
|Back Pain Chronic Low Back Pain Internal Disc Disruption Degenerative Disc Disease||Biological: BIOSTAT BIOLOGX Drug: Saline||Phase 3|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||May 2013|
Experimental: BIOSTAT BIOLOGX
One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc
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
Other Name: Fibrin Sealant
Placebo Comparator: Saline
One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc
One injection of up to 4 mL of saline using the Biostat Delivery Device
Other Name: 0.9% w/v Sodium Chloride Injection, USP
- Subject Composite Success [ Time Frame: 26 weeks ]Subject success based on a composite of minimum 30% decrease in low back pain, 30% improvement in function, maintenance of neurological status, no secondary interventions, and no serious adverse events.
- Visual Analog Scale for Low Back Pain [ Time Frame: 26-weeks ]
Percent of subjects achieving a minimum 30% decrease in pain from baseline.
The visual analog scale is a horizontal 100 mm line anchored on the left with the words "No Pain" and on the right with the words "Worst Possible Pain". Scores were obtained by measuring the distance in millimeters from the left origin of the line (0) to the point indicated with a slash placed by the subject to indicate the subject's level of low back pain experienced over the last week.
- Roland-Morris Disability Questionnaire Score [ Time Frame: 26-weeks ]
Percent of subjects achieving a minimum 30% decrease in Roland-Morris Disability Questionnaire score
The Roland-Morris Disability Questionnaire is a widely studied and frequently used instrument for the assessment of function and disability related to low back pain. The questionnaire consists of 24 statements related to how a subject's back condition affects various activities of daily living. Subjects marked whether the statement either applied to them or did not apply at the time they responded to the statements. The score is the total number of questions with which the subject agreed. A higher score indicates less function and greater disability.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01011816
|Principal Investigator:||Kevin J Pauza, MD||Spine Specialists PA|