A Prospective, Randomized, Multicenter Study to Demonstrate

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 including a post-approval amendment with follow-up visits at 7 & 10 years for eligible subjects. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01283438
Study type	Interventional
Source	Intrinsic Therapeutics
Contact
Status	Active, not recruiting
Phase	Phase 4
Start date	December 17, 2010
Completion date	June 2025

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms