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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Barricaid | Experimental | CE Marked Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Barricaid | Device | Implanted intra-operatively during discectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient function as measured on Oswestry Disability Index (ODI) | 15-point reduction in ODI at 24-month visit relative to baseline | 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) | 24 months |
| Clinically symptomatic recurrent herniation at the index level, confirmed by imaging | Performed at 24 months by the Investigator. | 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. | 24 months |
| Removal or revision of the implant | Any removal or revision of the implant will be measured as a safety outcome. | 24 months |
| Supplemental fixation applied at the treated level | Any supplemental fixation applied at the treated level will be tracked. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Back Pain on Visual Analog Scale (VAS) | Back pain on VAS will be tracked. | 24 months |
| Leg Pain on Visual Analog Scale (VAS) | Leg pain assessment will be tracked. Patient reported outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudius Thome, PhD | University of Innsbruck, Department of Neurosurgery | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25983843 | Result | Lequin MB, Barth M, Thome C, Bouma GJ. Primary limited lumbar discectomy with an annulus closure device: one-year clinical and radiographic results from a prospective, multi-center study. Korean J Spine. 2012 Dec;9(4):340-7. doi: 10.14245/kjs.2012.9.4.340. Epub 2012 Dec 31. | |
| 23377540 | Result | Bouma GJ, Barth M, Ledic D, Vilendecic M. The high-risk discectomy patient: prevention of reherniation in patients with large anular defects using an anular closure device. Eur Spine J. 2013 May;22(5):1030-6. doi: 10.1007/s00586-013-2656-1. Epub 2013 Feb 3. |
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| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 24 months |
| Quality of life on SF36 | Quality of life on SF36 will be tracked. Patient reported outcome. | 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) | 24 months |
| Frequency of AE's | Frequency of AE's reported throughout the study will be tracked and analyzed at the 24 month visit. | 24 months |