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A Prospective, Randomized, Multicenter Study to Demonstrate the Superiority of the Barricaid to Discectomy for Primary Lumbar Disc Herniation

2014-09-25 15:08:23 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Lumbar Disc Herniation

Intervention

Barricaid, Standard of Care

Location

LKH Graz
Graz
Mecklenburg-Vorpommern
Austria
59037

Status

Recruiting

Source

Intrinsic Therapeutics

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-09-25T15:08:23-0400

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