TY - JOUR
T1 - Risk factors for early reherniation after lumbar discectomy with or without annular closure: results of a multicenter randomized controlled study
AU - Kienzler, Jenny C.
AU - Fandino, Javier
AU - van de Kelft, Erik
AU - Eustacchio, Sandro
AU - The Barricaid® Annular Closure RCT Study Group
AU - Bouma, Gerrit Joan
N1 - Funding Information: 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. Publisher Copyright: © 2020, Springer-Verlag GmbH Austria, part of Springer Nature.
PY - 2021/1
Y1 - 2021/1
N2 - 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.
AB - 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.
KW - Annular closure device
KW - Annulus fibrosus
KW - Disc herniation
KW - Lumbar discectomy
KW - Reherniation
KW - Risk factors
UR - http://www.scopus.com/inward/record.url?scp=85093072828&partnerID=8YFLogxK
U2 - https://doi.org/10.1007/s00701-020-04505-4
DO - https://doi.org/10.1007/s00701-020-04505-4
M3 - Article
C2 - 33085021
SN - 0001-6268
VL - 163
SP - 259
EP - 268
JO - Acta neurochirurgica
JF - Acta neurochirurgica
IS - 1
ER -