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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Implanted intra-operatively during discectomy
Patient function as measured on Oswestry Disability Index (ODI)
15-point reduction in ODI at 24-month visit relative to baseline
Time frame: 24 months
Disc height maintenance as measured from standing x-rays
75% maintenance at 2 years relative to pre-op, measured by independent radiologist, (reference: Yorimitsu, et al, Spine 2001)
Time frame: 24 months
Clinically symptomatic recurrent herniation at the index level, confirmed by imaging
Performed at 24 months by the Investigator.
Time frame: 24 months
Migration of the bone anchor posteriorly into the epidural space
Radiographic imaging taken to ensure no migration of the device. Assessment made by the Investigator and Radiographic Core lab.
Time frame: 24 months
Removal or revision of the implant
Any removal or revision of the implant will be measured as a safety outcome.
Time frame: 24 months
Supplemental fixation applied at the treated level
Any supplemental fixation applied at the treated level will be tracked.
Time frame: 24 months
Back Pain on Visual Analog Scale (VAS)
Back pain on VAS will be tracked.
Time frame: 24 months
Leg Pain on Visual Analog Scale (VAS)
Leg pain assessment will be tracked. Patient reported outcome.
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Time frame: 24 months
Quality of life on SF36
Quality of life on SF36 will be tracked. Patient reported outcome.
Time frame: 24 months
Comparison of neurological symptoms on clinical examination, relative to baseline
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)
Time frame: 24 months
Frequency of AE's
Frequency of AE's reported throughout the study will be tracked and analyzed at the 24 month visit.
Time frame: 24 months