Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System

Exclusion Criteria

• •Cauda equina syndrome.
• •Active malignancy or tumor as source of symptoms.
• •Current infection or prior history of spinal infection (e.g., discitis, septic arthritis, epidural abscess) or an active systemic infection.
• •Previous lumbar spine surgery.
• •Evidence of prior lumbar vertebral body fracture.
• •Disc bulge/protrusion or focal herniation at the symptomatic level(s) \> 4 mm.
• •Presence of disc extrusion or sequestration.
• •Leg pain is greater than 50% of low back pain as measured on a visual analog scale.
• •Leg pain that extends below the knee.
• •Lumbar intervertebral foramen stenosis at the affected level(s) resulting in significant spinal nerve root compression (effacement of the majority of periganglion fat and loss of CSF signal around the nerve rootlets).
• •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 at the symptomatic level(s) on lumbar flexion-extension radiographs indicated by \>4.5 mm of translation or angular motion \>15° at L1-L2, L2-L3, or L3-L4; \>20° at L4-L5; or \>25° at L5-S1.
• •Diagnostic medial branch block or facet joint injection indicate facet joint involvement.
• •Diagnostic sacroiliac injection indicates sacroiliac joint involvement for those patients with pain in the sacral region.
• •Sustained relief (\>3 months) of low back pain obtained with epidural injection of corticosteroids.
• •Symptomatic involvement of more than two lumbar disc levels determined from discography.
• •Neurological examination shows findings of radiculopathy or a significant underlying neurological condition (motor strength \<4; sensory assessment abnormal; or reflexes absent or hyperactive with clonus).
• •Prior thermal intradiscal procedure (e.g., intradiscal electrothermal therapy, intradiscal radiofrequency thermocoagulation).
• •Any lumbar intradiscal injection procedure other than discography (e.g., injection of corticosteroids, methylene blue, dextrose, or glucosamine and chondroitin sulfate).
• •Significant systemic disease, including unstable angina, autoimmune disease, rheumatoid arthritis, and muscular dystrophy.
• •Congenital or acquired coagulopathy or thrombocytopenia; or currently taking anticoagulant, antineoplastic, antiplatelet, or thrombocytopenia-inducing medications; or undergoing radiation therapy.
• •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.
• •Known or suspected hypersensitivity or allergy to drugs or components of the fibrin sealant (fibrinogen, thrombin, aprotinin, CaCl2) used in the procedure.
• •History of, or current psychiatric or psychological condition, or 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.
• •Body habitus precludes adequate fluoroscopic visualization for the procedure or the procedure is physically impossible using the device.
• •Concomitant conditions requiring daily oral steroid use 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, personal injury compensation or litigation claims.
• •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.