Barricaid EU Post Market Study for Primary Lumbar Disc Herniation
This study has been completed.
Information provided by (Responsible Party):
First received: January 4, 2012
Last updated: November 7, 2016
Last verified: November 2016
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
Resource links provided by NLM:
Further study details as provided by Intrinsic Therapeutics:
Primary Outcome Measures:
- Patient function as measured on Oswestry Disability Index (ODI) [ Time Frame: 24 months ]15-point reduction in ODI at 24-month visit relative to baseline
- Disc height maintenance as measured from standing x-rays [ Time Frame: 24 months ]75% maintenance at 2 years relative to pre-op, measured by independent radiologist, (reference: Yorimitsu, et al, Spine 2001)
- Clinically symptomatic recurrent herniation at the index level, confirmed by imaging [ Time Frame: 24 months ]Performed at 24 months by the Investigator.
- Migration of the bone anchor posteriorly into the epidural space [ Time Frame: 24 months ]Radiographic imaging taken to ensure no migration of the device. Assessment made by the Investigator and Radiographic Core lab.
- Removal or revision of the implant [ Time Frame: 24 months ]Any removal or revision of the implant will be measured as a safety outcome.
- Supplemental fixation applied at the treated level [ Time Frame: 24 months ]Any supplemental fixation applied at the treated level will be tracked.
Secondary Outcome Measures:
- Back Pain on Visual Analog Scale (VAS) [ Time Frame: 24 months ]Back pain on VAS will be tracked.
- Leg Pain on Visual Analog Scale (VAS) [ Time Frame: 24 months ]Leg pain assessment will be tracked. Patient reported outcome.
- Quality of life on SF36 [ Time Frame: 24 months ]Quality of life on SF36 will be tracked. Patient reported outcome.
- Comparison of neurological symptoms on clinical examination, relative to baseline [ Time Frame: 24 months ]Patient will have the following examinations: straight leg raising, deep tendon reflexes, forward bend, motor strength examination (hip flexors, knee extensors, tibialis, long toe extensors), and sensory (light touch, pin prick, or vibration)
- Frequency of AE's [ Time Frame: 24 months ]Frequency of AE's reported throughout the study will be tracked and analyzed at the 24 month visit.
|Study Start Date:||April 2009|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
CE Marked Device
Implanted intra-operatively during discectomy
Contacts and Locations
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