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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery with 6mm ACD | Other | ACD medical device (non-experimental). Surgical device implantation after standard lumbar discectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6mm annular closure device | Device | 6MM Barricaid annular closure device implantation following standard lumbar discectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device stability | To be considered a success the subjects would require to have a lack of implant migration through 3 months after surgery | 3 months post implantation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through 24Month post implantation |
| Visual Analog Scale - leg pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OLVZ Aalst | Aalst | 9300 | Belgium | |||
| Klinikum Itzehoe |
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| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
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Multicenter non-randomized device trial
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Change in leg pain as measured using a Visual Analog Scale (VAS), on a scale of 0-100, with lower values representing better outcome.
| 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. | Through 24Month post implantation |
| Oswestry Disability Index | Change in function as measured using the Oswestry Disability Index (ODI) | Through 24Month post implantation |
| Itzehoe |
| 25524 |
| Germany |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |