Barricaid EU Post Market Study for Primary Lumbar Disc Herniation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01534065|
Recruitment Status : Completed
First Posted : February 16, 2012
Last Update Posted : November 9, 2016
Information provided by (Responsible Party):
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.
|Condition or disease||Intervention/treatment||Phase|
|Lumbar Disc Herniation||Device: Barricaid||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
CE Marked Device
Implanted intra-operatively during discectomy
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.
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