NCT01283438

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

A Prospective, Randomized, Multicenter Study to Demonstrate the Superiority of the Barricaid® to Discectomy for Primary Lumbar Disc Herniation: Extended Follow-Up of the Barricaid® Annular Closure Device (ACD) Randomized Control Trial (RCT) Postmarket Cohort for Lumbar Disc Herniation and Interaction With Other Risk Factors

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 554 (actual)
• Sponsor: Intrinsic Therapeutics · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Lumbar Disc Herniation

Interventions

Type	Name	Description
DEVICE	Barricaid	Annular closure device
DEVICE	Standard of Care	Standard Limited discectomy

Timeline

• Start date: 2010-12-17
• Primary completion: 2016-10-01
• Completion: 2025-06-01
• First posted: 2011-01-26
• Last updated: 2023-09-28

Locations

21 sites across 6 countries: Austria, Belgium, France, Germany, Netherlands, Switzerland