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

Completed · Not applicable

Conditions studied: Low Back Pain

In brief

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.

Key facts

Study ID

NCT00693784

Run by

Spinal Restoration, Inc.

People needed

15

Starts

2008-06-01

Expected to finish

2011-01-01

Last updated by the study team

2015-06-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Bethesda, Maryland, United States
• Study site — Tyler, Texas, United States
• Study site — Bellingham, Washington, United States

Full record on ClinicalTrials.gov

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