Status:
COMPLETED
Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® Disc Augmentation System: A Pilot Study
Lead Sponsor:
Spinal Restoration, Inc.
Conditions:
Low Back Pain
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 ...
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 inter...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00693784
Start Date
June 1 2008
End Date
January 1 2011
Last Update
June 22 2015
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Bethesda, Maryland, United States, 20814
2
Tyler, Texas, United States, 75701
3
Bellingham, Washington, United States, 98226