A Post Marketing Surveillance Study To Monitor The Early Safety And Performance Of The BARRICAID® Anular Closure Device In The Treatment Of Radicular Pain Caused By Primary Lumbar Disc Herniation
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Lumbar Disc Herniation
- Sponsor
- Intrinsic Therapeutics
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Device stability
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This study is a prospective, multi-center study to monitor the early safety and performance of one iteration of the Barricaid Anular Closure Device (ACD) - 6mm anchor width, when used as an adjunct to limited discectomy.
Detailed Description
This study is planned to collect information on use of the Barricaid ACD with an anchor width of 6mm. Other iterations of the device are made with an 8mm wide anchor. The narrower anchor was designed to optimize surgeon visualization during implantation, and has undergone all appropriate rigorous testing prior to release. Safety will be evaluated to demonstrate acceptable levels of device-related and procedure-related complications. This limited market release will allow its performance to be evaluated by examining the effects on reoperation, device deficiencies, patient pain scores and disability after discectomy with ACD.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 to 75 years old (male or female).
- •Patients with posterior or posterolateral disc herniations at one level 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, or requires immediate surgery to prevent permanent disability.
- •Minimum posterior disc height of 5mm 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.
- •Psychosocially, mentally and physically able to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.
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 surgery at the index lumbar level.
- •Subject requiring a spine DEXA (i.e., patients with SCORE of ≥ 6) with a T Score less than -2.0 at the index level. For patients with a herniation at L5/S1, the average T score of L1-L4 shall be used.
- •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
Device stability
Time Frame: 3 months post implantation
To be considered a success the subjects would require to have a lack of implant migration through 3 months after surgery
Secondary Outcomes
- Oswestry Disability Index(Through 24Month post implantation)
- Visual Analog scale - back pain(Through 24Month post implantation)
- Device condition, reoperation at index level and long term performance(Through 24Month post implantation)
- Visual Analog Scale - leg pain(Through 24Month post implantation)