Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® Disc Augmentation System: A Pilot Study

Exclusion Criteria

• •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.