gms | German Medical Science

63rd Annual Meeting of the German Society of Neurosurgery (DGNC)
Joint Meeting with the Japanese Neurosurgical Society (JNS)

German Society of Neurosurgery (DGNC)

13 - 16 June 2012, Leipzig

Would you ride your bicycle with a puncture in the tire? Two-year benefits of anular defect closure after lumbar discectomy

Meeting Abstract

  • G.J. Bouma - Sint Lucas Andreas Ziekenhuis, Spine Center, Amsterdam, Netherlands
  • M. Barth - Neurochirurgiche Klinik, Universität Mannheim, Germany
  • M. Vilendecic - University Hospital Dubrava, Zagreb, Croatia
  • D. Ledic - University Hospital, Rijeka, Croatia
  • R. Bartels - CWZ Department of Neurosurgery Nijmegen, Netherlands
  • E.A. Al-Kahlout - Klinikum Duisburg GmbH, Duisburg, Germany

Deutsche Gesellschaft für Neurochirurgie. Japanische Gesellschaft für Neurochirurgie. 63. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie (DGNC), Joint Meeting mit der Japanischen Gesellschaft für Neurochirurgie (JNS). Leipzig, 13.-16.06.2012. Düsseldorf: German Medical Science GMS Publishing House; 2012. DocSA.08.03

DOI: 10.3205/12dgnc354, URN: urn:nbn:de:0183-12dgnc3546

Published: June 4, 2012

© 2012 Bouma et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.


Outline

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Objective: Closing anular defects with a mechanical barrier after discectomy may reduce the incidence of re-herniations, and subsequent complications. This technology may also allow for the maintenance of pre-operative disc height by giving surgeons to the opportunity to preserve more nuclear material. The purpose of this prospective, multi-center study was to evaluate the safety and performance of the Barricaid endoprosthesis for anular closure.

Methods: The Barricaid endoprosthesis consists of a woven-polyester mesh intended to block an anular defect while anchored to the adjacent vertebral bodies by a titanium bone anchor. 75 primary discectomy patients were enrolled under two similar protocols at 6 European sites. Inclusion criteria included: sciatica unresponsive to conservative therapy, minimum Oswestry (ODI) and VAS leg (ipsilateral) scores of at least 40 out of 100, and radiographic confirmation of one-level lumbar disc herniation. Subjects were evaluated pre-operatively and at 6 weeks, 3, 6, 12, and 24 months postop. VAS (back and legs), ODI, SF-36, and x-rays were obtained at each follow-up. MRs and CTs were taken at 12 and 24 months.

Results: Data were available for 70 patients at the one-year time point, and 41 patients at the two-year time point. There have been no anchor migrations, and one recurrent herniation with an improperly placed device. Clinical outcomes at pre-operative to 12 months and 24 months improved as follows: VAS Leg: 80.9 to 11.8 to 13.4; VAS Back: 61.3 to 20 to 13.6; ODI: 61.3 to 16.1 to 12.6; MCS: 46.76 to 73.6 to 75.16; PCS: 29.88 to 73.14 to 77.26. Defining clinical significance as a reduction of at least 20 points in VAS or at least 15 points in ODI at the 24 month follow-up, 93% of subjects exhibited clinically significant reductions in VAS ipsilateral leg pain, 98% in ODI and 85% in VAS back pain. An average of 91.3% of pre-operative disc height was maintained at 12 months and 88.4% at 24 months.

Conclusions: Implantation of the Barricaid endoprosthesis as an adjunct to limited discectomy has been shown to be safe. To date, the device is performing its function of retaining nuclear material within the disc and in turn allowing for the maintenance of pre-operative disc height. Early results show that patients treated with the ACD have experienced excellent clinical outcomes.