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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lumbar Disc Herniation
- Sponsor
- Intrinsic Therapeutics
- Enrollment
- 45
- Primary Endpoint
- Patient function as measured on Oswestry Disability Index (ODI)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 to 75 years old (male or female).
- •Patients with posterior or posterolateral disc herniations at one or two levels between L1 and S1 with radiographic confirmation of neural compression using CT and/or MRI.
- •At least six (6) weeks of failed, conservative treatment prior to surgery, including physical therapy, use of anti-inflammatory medications at maximum specified dosage and/or administration of epidural/facet injections.;
- •Minimum posterior disc height of 3mm at the index level(s).
- •Lower back pain and/or sciatica with or without spinal claudication.
- •Oswestry Questionnaire score of at least 40/100 at baseline.
- •VAS leg pain of at least 40/100 at baseline.
Exclusion Criteria
- •Spondylolisthesis Grade II or higher
- •Subject requires uni or bilateral facetectomy to treat leg/back pain
- •Subject has back or non-radicular leg pain of unknown etiology.
- •Prior fusion (with or without instrumentation), motion preservation, facetectomy or IDET surgery at the index lumbar vertebral level
- •Subject's requiring a spine DEXA (i.e., patients with SCORE of ≥ 6) with a T Score less than -2.0 at the index level.
- •Subject has clinically compromised vertebral bodies at the index level(s) due to any traumatic, neoplastic, metabolic, or infectious pathology.
- •Subject has sustained pathologic fractures of the vertebra or multiple fractures of the vertebra or hip.
- •Subject has scoliosis of greater than ten (10) degrees (both angular and rotational).
- •Any metabolic disease bone disease that has not been stabilized for at least three months (e.g., Paget's disease, osteomalacia, osteogenesis imperfecta, thyroid and/or parathyroid gland disorder, etc.).
- •Subject has an active infection either systemic or local.
Outcomes
Primary Outcomes
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 Outcomes
- Back Pain on Visual Analog Scale (VAS)(24 months)
- Leg Pain on Visual Analog Scale (VAS)(24 months)
- Quality of life on SF36(24 months)
- Comparison of neurological symptoms on clinical examination, relative to baseline(24 months)
- Frequency of AE's(24 months)