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Primary limited lumbar discectomy with an annulus closure device: one-year clinical and radiographic results from a prospective, multi-center study.

Lequin MB, Barth M, Thomė C, Bouma GJ - Korean J Spine (2012)

Bottom Line: Surgeons face the dilemma between limited nucleus removal which is associated with a higher risk of recurrence, or more aggressive nucleus removal which may lead to disc height loss and persistent back-pain. annulus closure devices may allow for the benefits of limited nucleus removal without the increased risk of recurrence.One reherniation has occurred (2.4%), which was associated with a misplaced device.Using such a device should provide the surgeon increased confidence in minimizing nucleus removal, which, in turn, may preserve disc height and biomechanics, reducing degeneration and associated poor clinical outcomes in the long-term.

View Article: PubMed Central - PubMed

Affiliation: Department of Neurosurgery, Sint Lucas-Andreas Ziekenhuis and Academic Medical Center, Amsterdam, The Netherlands.

ABSTRACT

Objective: Discectomy as a treatment for herniated lumbar discs results in outcomes after surgery that are not uniformly positive. Surgeons face the dilemma between limited nucleus removal which is associated with a higher risk of recurrence, or more aggressive nucleus removal which may lead to disc height loss and persistent back-pain. annulus closure devices may allow for the benefits of limited nucleus removal without the increased risk of recurrence. This is an interim report of an ongoing 24-month post-marketing study of the Barricaid® annulus closure device, consisting of a flexible polymer mesh that blocks the defect, held in place by a titanium bone anchor.

Methods: We prospectively enrolled 45 patients at four hospitals, and implanted the Barricaid® after a limited discectomy. annulus defect size and volume of removed nucleus were recorded. Reherniations were reported, pain and function were monitored and imaging was performed at regular intervals during 24 months of follow-up.

Results: At 12 months postsurgery, pain and function were significantly improved, comparing favorably to reported results from limited discectomy. Disc height has been well maintained. One reherniation has occurred (2.4%), which was associated with a misplaced device. No device fracture, subsidence or migration has been observed.

Conclusion: The use of an annulus closure device may provide a reduction in reherniation rate for lumbar discectomy patients with large annulus defects who are at the greatest risk of recurrence. Using such a device should provide the surgeon increased confidence in minimizing nucleus removal, which, in turn, may preserve disc height and biomechanics, reducing degeneration and associated poor clinical outcomes in the long-term. A randomized multicenter study evaluating limited discectomy with and without the Barricaid® is currently underway, and will provide a higher level of evidence.

No MeSH data available.


Related in: MedlinePlus

Diagram (A) and intraoperative fluoroscopy image (B) showing insertion of the Barricaid device.
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Figure 3: Diagram (A) and intraoperative fluoroscopy image (B) showing insertion of the Barricaid device.

Mentions: Each surgery was carried out by one of eight neurosurgeons, all well-experienced in lumbar disc surgery. Prior to study initiation, surgeons took an instructional course which included "hands-on" training of inserting the Barricaid® device in cadaver specimens or in an artificial lumbar spine, though none had implanted any in living humans. In all subjects, a limited discectomy was performed. Any disc material removed, either from within or outside the disc space, was placed dry in a syringe and the volume was measured and recorded. After completion of the discectomy, the size of the annulus defect was measured using sizing probes of 1mm increments. If the defect was taller than 6mm or wider than 10mm, implantation of the annulus closure device was not attempted. In no case, however, the defect exceeded these size limits. Subsequently, a sizing trial, designed to replicate the size and shape of the loaded delivery tool, was used to confirm access through the lamina and the appropriate angle of approach to the disc. Then the delivery tool was placed in the disc under fluoroscopic control, ensuring that the angle of approach was parallel to the target endplate in the region of implantation. Holding the delivery tool firmly in position, the anchor was hammered into the endplate, thereby simultaneously placing the mesh in position within the disc (Fig. 3).


Primary limited lumbar discectomy with an annulus closure device: one-year clinical and radiographic results from a prospective, multi-center study.

Lequin MB, Barth M, Thomė C, Bouma GJ - Korean J Spine (2012)

Diagram (A) and intraoperative fluoroscopy image (B) showing insertion of the Barricaid device.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4430560&req=5

Figure 3: Diagram (A) and intraoperative fluoroscopy image (B) showing insertion of the Barricaid device.
Mentions: Each surgery was carried out by one of eight neurosurgeons, all well-experienced in lumbar disc surgery. Prior to study initiation, surgeons took an instructional course which included "hands-on" training of inserting the Barricaid® device in cadaver specimens or in an artificial lumbar spine, though none had implanted any in living humans. In all subjects, a limited discectomy was performed. Any disc material removed, either from within or outside the disc space, was placed dry in a syringe and the volume was measured and recorded. After completion of the discectomy, the size of the annulus defect was measured using sizing probes of 1mm increments. If the defect was taller than 6mm or wider than 10mm, implantation of the annulus closure device was not attempted. In no case, however, the defect exceeded these size limits. Subsequently, a sizing trial, designed to replicate the size and shape of the loaded delivery tool, was used to confirm access through the lamina and the appropriate angle of approach to the disc. Then the delivery tool was placed in the disc under fluoroscopic control, ensuring that the angle of approach was parallel to the target endplate in the region of implantation. Holding the delivery tool firmly in position, the anchor was hammered into the endplate, thereby simultaneously placing the mesh in position within the disc (Fig. 3).

Bottom Line: Surgeons face the dilemma between limited nucleus removal which is associated with a higher risk of recurrence, or more aggressive nucleus removal which may lead to disc height loss and persistent back-pain. annulus closure devices may allow for the benefits of limited nucleus removal without the increased risk of recurrence.One reherniation has occurred (2.4%), which was associated with a misplaced device.Using such a device should provide the surgeon increased confidence in minimizing nucleus removal, which, in turn, may preserve disc height and biomechanics, reducing degeneration and associated poor clinical outcomes in the long-term.

View Article: PubMed Central - PubMed

Affiliation: Department of Neurosurgery, Sint Lucas-Andreas Ziekenhuis and Academic Medical Center, Amsterdam, The Netherlands.

ABSTRACT

Objective: Discectomy as a treatment for herniated lumbar discs results in outcomes after surgery that are not uniformly positive. Surgeons face the dilemma between limited nucleus removal which is associated with a higher risk of recurrence, or more aggressive nucleus removal which may lead to disc height loss and persistent back-pain. annulus closure devices may allow for the benefits of limited nucleus removal without the increased risk of recurrence. This is an interim report of an ongoing 24-month post-marketing study of the Barricaid® annulus closure device, consisting of a flexible polymer mesh that blocks the defect, held in place by a titanium bone anchor.

Methods: We prospectively enrolled 45 patients at four hospitals, and implanted the Barricaid® after a limited discectomy. annulus defect size and volume of removed nucleus were recorded. Reherniations were reported, pain and function were monitored and imaging was performed at regular intervals during 24 months of follow-up.

Results: At 12 months postsurgery, pain and function were significantly improved, comparing favorably to reported results from limited discectomy. Disc height has been well maintained. One reherniation has occurred (2.4%), which was associated with a misplaced device. No device fracture, subsidence or migration has been observed.

Conclusion: The use of an annulus closure device may provide a reduction in reherniation rate for lumbar discectomy patients with large annulus defects who are at the greatest risk of recurrence. Using such a device should provide the surgeon increased confidence in minimizing nucleus removal, which, in turn, may preserve disc height and biomechanics, reducing degeneration and associated poor clinical outcomes in the long-term. A randomized multicenter study evaluating limited discectomy with and without the Barricaid® is currently underway, and will provide a higher level of evidence.

No MeSH data available.


Related in: MedlinePlus