Ignite Creation Date:
2024-05-05 @ 11:13 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01283438
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-28
First Post:
2011-01-06
Brief Title:
A Prospective Randomized Multicenter Study to Demonstrate the Superiority of the Barricaid to Discectomy for Primary Lumbar Disc Herniation
Sponsor:
Intrinsic Therapeutics
Organization:
Intrinsic Therapeutics
Study Overview
Official Title:
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:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None