Barricaid EU Post Market Study for Primary Lumbar Disc Herniation

Lumbar Disc Herniation Clinical Trial

Official title: A Multi-center, Post Marketing Surveillance Study to Monitor the Safety and Performance of the Barricaid® ARD in the Treatment of Back and Radicular Pain Caused by Primary Lumbar Disc Herniation

Status Completed

Clinical Trial Summary

The purpose of this multi-center post marketing surveillance study is to monitor the safety and performance of the Barricaid® ARD when used to surgically reconstruct the anulus of the L1 - S1 spinal disc.

Clinical Trial Description

The purpose of this prospective, randomized, multicenter study is to demonstrate the superiority of the Barricaid® when used as an adjunct to a primary lumbar limited discectomy (as described by Spengler), to limited discectomy alone, with regard to preventing reherniation and the recurrence of pain or dysfunction. Patients, ages 21 - 75, will have, in part, a positive straight leg raise (or positive femoral stretch, as appropriate), MRI confirmation of a disc herniation, and minimum Oswestry and VAS leg scores of 40 out of 100 to qualify for this study. Additional patient criteria can be found in the inclusion/exclusion criteria section.

Superiority of the Barricaid relative to limited discectomy alone will be based on a comparison of overall success rates of the Barricaid and a concurrent group (randomized) of control patients treated by primary lumbar limited discectomy at select European (approximately 15-20) sites.

This study has two co-primary endpoints. Success of the study will be based on the Barricaid population achieving statistical superiority over the concurrently randomized non-implanted limited discectomy population at 2 years. ;

Related Conditions & MeSH terms

• Hernia
• Lumbar Disc Herniation

• NCT number: NCT01534065
• Study type: Interventional
• Source: Intrinsic Therapeutics
• Status: Completed
• Phase: N/A
• Start date: April 2009
• Completion date: March 2013