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A randomized study to demonstrate the superiority of the Barricaid® when used in conjunction with limited discectomy, compared to limited discectomy alone, with regard to preventing reherniation and the recurrence of pain or dysfunction.
The Barricaid is indicated for patients with radiculopathy (with or without back pain), a positive Straight Leg Raise (L45, L5S1) or femoral stretch test (L12, L23, L34), and a posterior or posterolateral herniation at one level between L1 and S1 with radiographic confirmation of neural compression using MRI who are found to have an annular defect (post discectomy) which measures between 4mm and 6mm tall and between 6mm and 10mm wide, have a minimum posterior disc height of 5mm, and have failed at least 6 weeks of conservative treatment.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Lumbar Disc Herniation
Barricaid, Standard of Care
Published on BioPortfolio: 2014-09-25T15:08:23-0400
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Post-Marketing Clinical Follow-up of an Anular Closure System (Barricaid®) to Confirm Comparability of Outcome between Devices with Subcomponents from Two Different Suppliers
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An INTERVERTEBRAL DISC in which the NUCLEUS PULPOSUS has protruded through surrounding ANNULUS FIBROSUS. This occurs most frequently in the lower lumbar region.
The replacement of intervertebral discs in the spinal column with artificial devices. The procedure is done in the lumbar or cervical spine to relieve severe pain resulting from INTERVERTEBRAL DISC DEGENERATION.
The dissolving of the NUCLEUS PULPOSUS, the semi-gelatinous tissue of a displaced INTERVERTEBRAL DISC. It is usually achieved by the direct injection of a proteolytic enzyme, especially CHYMOPAPAIN, into the herniated disc.
The minimum acceptable patient care, based on statutes, court decisions, policies, or professional guidelines.
Excision, in part or whole, of an intervertebral disk. The most common indication is disk displacement or herniation. In addition to standard surgical removal, it can be performed by percutaneous diskectomy (DISKECTOMY, PERCUTANEOUS) or by laparoscopic diskectomy, the former being the more common.
Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...
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