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Risk factors for early reherniation after lumbar discectomy with or without annular closure: results of a multicenter randomized controlled study

Acta Neurochirurgica volume 163, pages 259–268 (2021)Cite this article

Abstract

Background

Reherniation after lumbar discectomy is classified as a failure and occurs in 3 to 18% of cases. Various risk factors for reherniation such as age, sex, body mass index, smoking, and size of annular defect have been reported. The aim of this study was to identify risk factors for early reherniation after one-level lumbar discectomy with or without annular closure within 3 months after surgery.

Methods

This study is based on data analysis of a prospective, multicenter randomized controlled trial in Europe. Patients included underwent standard lumbar discectomy—with or without implantation of an annular closure device (ACD). 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. A total of 276 patients were randomized to the ACD group (ACG) and 278 patients to the control group (CG).

Results

Four (1.5%) symptomatic reherniations occurred in the ACG and 18 (6.5%) in the CG. In the overall population, a significant correlation was found with recurrent herniation for disc degeneration (Pfirrmann p = 0.009) and a trend for current smoker status (p = 0.07). In CG, age ≥ 50 years (p = 0.05) and disc degeneration (Pfirrmann p = 0.026, Kellgren and Lawrence p = 0.013) were predictive factors for reherniation.

Conclusion

In the current study, risk factors for early recurrent disc herniation after lumbar discectomy were age ≥ 50 years and moderate disc degeneration. The annular closure device reduced the risk of early reherniation.

Trial registration

Clinicaltrials.gov NCT01283438

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Fig. 1

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Author information

Affiliations

  1. Department of Neurosurgery, Kantonsspital Aarau, Tellstrasse, 5001, Aarau, Switzerland

    Jenny C. Kienzler & Javier Fandino

  2. Department of Neurosurgery, AZ Nikolaas, Sint-Niklaas and Faculty of Medicine and Health Sciences, University of Antwerp, Antwerpen, Belgium

    Erik Van de Kelft

  3. Department of Neurosurgery, University Hospital Graz, Graz, Austria

    Sandro Eustacchio

  4. Department of Neurosurgery, OLVG Locatie West, Amsterdam, The Netherlands

    Gerrit Joan Bouma

Authors
  1. Jenny C. Kienzler
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  2. Javier Fandino
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  3. Erik Van de Kelft
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  4. Sandro Eustacchio
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  5. Gerrit Joan Bouma
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Consortia

The Barricaid® Annular Closure RCT Study Group

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. The study was supported by the Intrinsic Therapeutics, Inc., Woburn MA, USA. None of the authors received financial compensation for the work related to the study. The coauthor G.J. Bouma has received research grants from the Intrinsic Therapeutics. All other authors declared that they have no conflict of interest.

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Kienzler, J.C., Fandino, J., Van de Kelft, E. et al. Risk factors for early reherniation after lumbar discectomy with or without annular closure: results of a multicenter randomized controlled study. Acta Neurochir 163, 259–268 (2021). https://doi.org/10.1007/s00701-020-04505-4

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Keywords

  • Annulus fibrosus
  • Disc herniation
  • Annular closure device
  • Lumbar discectomy
  • Risk factors
  • Reherniation