Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System
Condition: Back Pain; Chronic Low Back Pain; Internal Disc Disruption; Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration; Back Pain; Low Back Pain
Intervention: BIOSTAT BIOLOGX; Saline
Intervention description: One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device; One injection of up to 4 mL of saline using the Biostat Delivery Device
Intervention MeSH terms: Fibrin Tissue Adhesive
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 220.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: intervertebral disk

Summary:

      The purpose of this investigation is to establish the safety and efficacy of the Biostat
      System when used for treatment of chronic low back (lumbar) pain due to symptomatic internal
      disc disruptions (IDD) by comparing safety and efficacy outcome measures between one group
      receiving BIOSTAT BIOLOGX® Fibrin Sealant through the Biostat® Delivery Device and another
      group receiving a preservative-free normal saline control delivered with the Biostat Delivery
      Device.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 or older 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.

          -  Chronic 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.

          -  Pretreatment baseline Roland-Morris Disability Questionnaire score of at least 9 on
             the 24-point questionnaire.

          -  Leg pain, if present, is of nonradicular origin, i.e., not due to stimulation of nerve
             roots or dorsal root ganglion of a spinal nerve by compressive forces.

          -  Leg pain, if present, does not extend below the knee and is no greater than 50% of low
             back pain as measured on a visual analog scale. If bilateral leg pain, the worst leg
             pain is no greater than 50% of low back pain.

          -  Low back pain unresponsive to at least 3 months of nonoperative care, which may
             include bed rest, antiinflammatory and analgesic medications, chiropractic
             manipulations, acupuncture, massage, physical therapy or home-directed lumbar exercise
             program.

          -  Diagnostic medial branch block or facet joint injection between 18 months and 2 weeks
             prior to the study procedure indicates no facet joint involvement.

          -  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 between 18 months and 2 weeks prior to the
             study procedure using pressure manometry and identification of an adjacent nonpainful
             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 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.