Low Back PainNCT00693784
Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® Disc Augmentation System: A Pilot Study
A study testing Biostat® Disc Augmentation System in people with Low Back Pain, run by Spinal Restoration, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Biostat® Disc Augmentation System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2008to Jan 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 (inclusive) and skeletally mature.
- Voluntarily signs the subject informed consent form and agrees to the release of medical information for purposes of this study (HIPAA authorization).
- Physically and mentally able to comply with the protocol, including ability to read and complete required forms, and willing and able to adhere to the follow-up requirements of the protocol.
- Low-back pain for at least 6 months.
- Pretreatment baseline low-back pain of at least 40 mm on a 100 mm visual analog scale.
- Referred leg pain, if present, is of noncompressive origin and there are no clinical findings of radiculopathy.
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- Low-back pain is greater than leg pain (if present) as measured on a visual analog scale. If bilateral leg pain, back pain is greater than worst leg pain.
- Low-back pain unresponsive to at least 6 weeks of nonoperative treatment, which may include bed rest, antiinflammatory and analgesic medications, chiropractic manipulations, acupuncture, massage, physical therapy or home-directed lumbar exercise program.
- Negative response to diagnostic medial branch block or facet joint injection.
- No sustained relief with epidural injection of corticosteroids.
- Diagnosis of symptomatic lumbar (L1/L2-L5/S1) internal disc disruption (IDD), which requires confirmation of discogenic pain at one or two contiguous levels through positive provocation discography performed using pressure manometry and identification of an adjacent normal disc. The disc provocation studies must precisely demonstrate concordant pain (<50 psi above opening pressure) and must demonstrate a fissure(s) in the outer one-third of the posterior or lateral anulus.
Who cannot join
- Cauda equina syndrome.
- Active malignancy or tumor as source of symptoms.
- Infection at the planned procedure site or active systemic infection.
- Previous lumbar spine surgery.
- Previous disc invasive treatment procedures at the affected level(s) (e.g., intradiscal electrothermal therapy, intradiscal radiofrequency thermocoagulation) in the past 12 months or intradiscal corticosteroid injection within the past 3 months.
- Evidence of prior lumbar vertebral body fracture or trauma.
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- Disc bulge/protrusion at the symptomatic level(s) > 4 mm.
- Presence of disc extrusion or sequestration.
- Clinical findings of lumbosacral motor or sensory radiculopathy.
- Leg pain is greater than low-back pain as measured on a visual analog scale.
- Lumbar intervertebral foramen stenosis at the affected level(s) resulting in significant spinal nerve root compression or impingement.
- Symptomatic central vertebral canal stenosis or absolute sagittal vertebral canal diameter < 9mm.
- Loss of disc space height at the symptomatic level(s) greater than one-third of an adjacent normal disc (or of the expected height in the case of an L5-S1 disc).
- Spondylolisthesis (≥ Grade 1) with or without spondylolysis at the symptomatic level(s).
- Lumbar spondylitis or other undifferentiated spondyloarthropathy.
- Dynamic instability on lumbar flexion-extension radiographs.
- Positive response to diagnostic medial branch block or facet joint injection.
- Positive response to diagnostic sacroiliac joint injection for those patients with pain in the sacral region
- Sustained relief obtained with epidural injection of corticosteroids.
- Symptomatic involvement of more than two lumbar disc levels.
- Congenital or acquired coagulopathy or thrombocytopenia; or currently taking anticoagulant, antineoplastic, antiplatelet, or thrombocytopenia-inducing medications.
- History of unexplained, easy, or persistent bruising or bleeding, bleeding from the gums, or bleeding problems experienced in previous surgical procedures.
- Aspirin or aspirin-containing medication taken ≤7 days prior to the procedure.
- Significant systemic disease, including unstable angina, autoimmune disease, rheumatoid arthritis, and muscular dystrophy.
- Known or suspected hypersensitivity or allergy to drugs or components of the fibrin sealant, including aprotinin, used in the procedure.
- History of, or current psychiatric condition, substance or alcohol abuse that would potentially interfere with the subject's participation in the study.
- Ongoing or previous participation in another drug or device clinical study within the previous 2 months.
- Subject known to be pregnant or nursing at time of enrollment or with plans to become pregnant within the planned length of follow-up (2 years).
- Body habitus precludes adequate fluoroscopic visualization for the procedure or the procedure is physically impossible using the device.
- Concomitant conditions requiring daily oral steroid usage for more than 30 days in the preceding 90 days.
- Pending litigation against a health care professional, except where required by the insurer as a condition of coverage.
- Prisoner or active military personnel who would not be available for follow-up.
- Presence of ferromagnetic implants that would disallow MRI of the symptomatic disc(s).
- Active or pending workers' compensation claims.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Bellingham, Washington, 98226
Study site
Bethesda, Maryland, 20814
Study site
Tyler, Texas, 75701
About this study
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
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.
Read the 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
- Being tested
- Biostat® Disc Augmentation System
- Keywords
- Intervertebral Disk, chronic low back pain, internal disc disruption, degenerative disc disease
- Medical subject headings
- Low Back Pain, Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biostat® Disc Augmentation SystemBiological
Delivery of Biostat BIOLOGX® Fibrin Sealant with the Biostat Delivery Device
| Study group | Role | What they receive |
|---|---|---|
| Biostat® Disc Augmentation System | Experimental | Delivery of Biostat BIOLOGX® Fibrin Sealant with the Biostat Delivery Device Receives: Biological: Biostat® Disc Augmentation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers and Types of Adverse Events (Only Number of Events is Reported in This Section - See Adverse Events Section for Further Detail)
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.
Measured: 104 weeks
Secondary outcomes (2)
Visual Analog Scale for Low-back Pain
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.
Measured: Baseline, 26-weeks (primary endpoint), 52-weeks, 104-weeks
Roland-Morris Disability Questionnaire
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.
Measured: Baseline, 26-weeks (primary endpoint), 52-weeks, 104-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionFeb 2009
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spinal Restoration, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin J Pauza, MD, Principal investigator, Spine Specialists, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00693784
- Sponsor's protocol ID
- SR-BX01P-2007
- Status last verified
- May 2015
- First submitted
- 4 Jun 2008
- Last updated
- 22 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00693784
- Acronym / sponsor ID
- SR-BX01P-2007
- Conditions
- Low Back Pain
- Keywords
- Intervertebral Disk, chronic low back pain, internal disc disruption, degenerative disc disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Spinal Restoration, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 9 Jun 2008 (estimated)
- Results
- Posted 29 Apr 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biostat® Disc Augmentation System | Experimental | Biological: Biostat® Disc Augmentation SystemDelivery of Biostat BIOLOGX® Fibrin Sealant with the Biostat Delivery Device |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18-75 (inclusive) and skeletally mature.
- Voluntarily signs the subject informed consent form and agrees to the release of medical information for purposes of this study (HIPAA authorization).
- Physically and mentally able to comply with the protocol, including ability to read and complete required forms, and willing and able to adhere to the follow-up requirements of the protocol.
- Low-back pain for at least 6 months.
- Pretreatment baseline low-back pain of at least 40 mm on a 100 mm visual analog scale.
Key exclusion criteria (34 listed)
- Cauda equina syndrome.
- Active malignancy or tumor as source of symptoms.
- Infection at the planned procedure site or active systemic infection.
- Previous lumbar spine surgery.
- Previous disc invasive treatment procedures at the affected level(s) (e.g., intradiscal electrothermal therapy, intradiscal radiofrequency thermocoagulation) in the past 12 months or intradiscal corticosteroid injection within the past 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biostat® Disc Augmentation SystemDelivery of Biostat BIOLOGX® Fibrin Sealant with the Biostat Delivery Device | Biological | Biostat® Disc Augmentation System |
Primary outcome
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
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.
2 secondary outcomes
Visual Analog Scale for Low-back Pain
Time frame: Baseline, 26-weeks (primary endpoint), 52-weeks, 104-weeks
Roland-Morris Disability Questionnaire
Time frame: Baseline, 26-weeks (primary endpoint), 52-weeks, 104-weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin J Pauza, MD principal investigator
Spine Specialists, PA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biostat® Disc Augmentation System in people with Low Back Pain, run by Spinal Restoration, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2015.