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Intraoperative findings, complications, and short-term results after lumbar microdiscectomy with or without implantation of annular closure device

Acta Neurochirurgica volume 163, pages 545–559 (2021)Cite this article

Abstract

Background

Standard microscopic lumbar discectomy (MLD) is a short operation with minimal blood loss, and a low rate of peri- and intraoperative complications. The objective of this study was to evaluate intraoperative findings, complications, and early postoperative neurological outcome (< 105 days) in patients undergoing MLD with or without implantation of an annular closure device (ACD).

Methods

This study is based on data analysis of a post-marketing, prospective, multicenter RCT in Europe including patients undergoing standard MLD with or without implantation of an ACD (Barricaid®, Intrinsic Therapeutics, Inc., Woburn, MA). Enrollment of 554 patients in 21 centers in Europe (Germany, Switzerland, Austria, Belgium, The Netherlands, and France) started in 2010 and was completed in October 2014, with 276 patients randomized to the ACD group and 278 to the control group.

Results

Mean operation time was 70 min in the ACD group and 52 min in the control group (p < 0.0001). Intraoperative fluoroscopy time was 24 s in the ACD group and 7 s in the control group (p < 0.0001). Average blood loss was 94.2 ml in the ACD group and 64.7 ml in the control group (p = 0.0001). Serious device- or procedure-related adverse events occurred in 3.7% (10/272) of the ACD group and 7.9% (22/278) of the control group. Dural injuries occurred in 13 (4.8%) patients in the ACD group and 7 (2.5%) in the control group. There was one device-related nerve root injury resulting in a nerve root amputation. Surgical complications included 3 hematomas in the ACD group and 4 in the control group; 3 infections occurred in both groups. Device migrations were documented in 3 patients in the ACD group. Patients in the ACD group (n = 7, 2.6%) underwent fewer reoperations compared with that in the control group (n = 16, 5.8%, OR = 2.3 (0.9–5.7)). Mean VAS leg pain at 3 months was 11.9 in the ACD and 15.1 in the control group, respectively.

Conclusion

Short-term outcome after MLD with or without implantation of ACD was similar in both groups. Patients included in the ACD group underwent fewer reoperations in the first 3 months after surgery. Nevertheless, longer operation time, higher amount of blood loss, and risk of nerve root lesion during device implantation should be considered additional risks in patients undergoing ACD implantation after MLD.

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Funding

This study was funded by Intrinsic Therapeutics, Inc., Woburn MA, USA. The sponsor had no role in the design or conduct of this research.

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Affiliations

  1. Department of Neurosurgery, Kantonsspital Aarau, Aarau, Switzerland

    Jenny C. Kienzler & Javier Fandino

  2. Department of Neurosurgery, Klinikum Augsburg, Augsburg, Germany

    Volkmar Heidecke

  3. Department of Neurosurgery, Centre Hospitalier Régional Universitaire of Lille, Lille, France

    Richard Assaker

  4. Department of Neurosurgery, Klinikum Frankfurt, Frankfurt, Germany

    Martin Barth

Authors
  1. Jenny C. Kienzler
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  2. Volkmar Heidecke
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  3. Richard Assaker
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  4. Javier Fandino
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  5. Martin Barth
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Corresponding author

Correspondence to Javier Fandino.

Ethics declarations

This study was approved by the local EC (Ethikkommission Nordwest- und Zentralschweiz, EKNZ, Nr. 2012-036). All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. All authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants; participation in speakers’ bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements), or non-financial interest (such as personal or professional relationships, affiliations, knowledge or beliefs) in the subject matter or materials discussed in this manuscript. None of the authors received financial compensation for the work related to the study.

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Kienzler, J.C., Heidecke, V., Assaker, R. et al. Intraoperative findings, complications, and short-term results after lumbar microdiscectomy with or without implantation of annular closure device. Acta Neurochir 163, 545–559 (2021). https://doi.org/10.1007/s00701-020-04612-2

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Keywords

  • Disc herniation
  • Intraoperative findings
  • Annular closure device