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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
20
6MM Barricaid annular closure device implantation following standard lumbar discectomy
OLVZ Aalst
Aalst, Belgium
Klinikum Itzehoe
Itzehoe, Germany
Device stability
To be considered a success the subjects would require to have a lack of implant migration through 3 months after surgery
Time frame: 3 months post implantation
Device condition, reoperation at index level and long term performance
Will be analyzed and compared to available clinical and commercial data on the Barricaid device
Time frame: Through 24Month post implantation
Visual Analog Scale - leg pain
Change in leg pain as measured using a Visual Analog Scale (VAS), on a scale of 0-100, with lower values representing better outcome.
Time frame: Through 24Month post implantation
Visual Analog scale - back pain
Change in back pain as measured using a Visual Analog Scale (VAS), on a scale of 0-100, with lower values representing better outcome.
Time frame: Through 24Month post implantation
Oswestry Disability Index
Change in function as measured using the Oswestry Disability Index (ODI)
Time frame: Through 24Month post implantation
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