Annular closure device lowers reoperation risk 4 years after lumbar discectomy

Dharmin Nanda1, Mark P Arts2, Larry E Miller3, Hans-Peter Köhler4, Jason M Perrin5, Charlotte Flüh6, Peter Vajkoczy7 1Department of Neurosurgery, Isala Klinieken, Zwolle, the Netherlands; 2Department of Neurosurgery, Haaglanden Medical Center Westeinde, The Hague, the Netherlands;...

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Autores principales:	Nanda D, Arts MP, Miller LE, Köhler HP, Perrin JM, Flüh C, Vajkoczy P
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2019
Materias:	annular closure device annulus fibrosus disc herniation lumbar discectomy randomized controlled trial reoperation sciatica Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/fdb0d0356eb9442e8032da82c49dfa52
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spelling	oai:doaj.org-article:fdb0d0356eb9442e8032da82c49dfa522021-12-02T06:52:19ZAnnular closure device lowers reoperation risk 4 years after lumbar discectomy1179-1470https://doaj.org/article/fdb0d0356eb9442e8032da82c49dfa522019-09-01T00:00:00Zhttps://www.dovepress.com/annular-closure-device-lowers-reoperation-risk-4-years-after-lumbar-di-peer-reviewed-article-MDERhttps://doaj.org/toc/1179-1470Dharmin Nanda1, Mark P Arts2, Larry E Miller3, Hans-Peter Köhler4, Jason M Perrin5, Charlotte Flüh6, Peter Vajkoczy7 1Department of Neurosurgery, Isala Klinieken, Zwolle, the Netherlands; 2Department of Neurosurgery, Haaglanden Medical Center Westeinde, The Hague, the Netherlands; 3Miller Scientific Consulting, Inc., Asheville, NC, USA; 4Department of Neurosurgery, Asklepios Westklinikum Hamburg, Hamburg, Germany; 5Department of Neurosurgery, University Clinic Mannheim, Mannheim, Germany; 6Department of Neurosurgery, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany; 7Department of Neurosurgery, Charité Universitätsmedizin, Berlin, GermanyCorrespondence: Dharmin NandaDepartment of Neurosurgery, Isala Klinieken, Dokter van Heesweg 2, AB Zwolle 8025, The NetherlandsTel +31 038 424 5000Email nanda@neurochirurgie-zwolle.nlObjective: To determine whether implanting an annular closure device (ACD) following a lumbar discectomy procedure in patients with large defects in the annulus fibrosus lowers the risk of reoperation after 4 years.Methods: In a multicenter randomized trial, patients with large annular defects following single-level lumbar discectomy were intraoperatively randomized to additionally receive an ACD or no treatment (Controls). Clinical and imaging follow-up were performed at routine intervals over 4 years of follow-up. Main outcomes included reoperations at the treated lumbar level, leg pain scores on a visual analog scale, Oswestry Disability Index (ODI), and Physical Component Summary (PCS) and Mental Component Summary (MCS) scores from the SF-36 questionnaire.Results: Among 550 patients (ACD 272, Control 278), the risk of reoperation over 4 years was 14.4% with ACD and 21.1% with Controls (P=0.03). The reduction in reoperation risk with ACD was not significantly influenced by patient age (P=0.51), sex (P=0.34), body mass index (P=0.21), smoking status (P=0.85), level of herniation (P=0.26), leg pain severity at baseline (P=0.90), or ODI at baseline (P=0.54). All patient-reported outcomes improved in each group from baseline to 4 years (all P<0.001). The percentage of patients who achieved the minimal clinically important difference without a reoperation was proportionally higher in the ACD group compared to Controls for leg pain (P=0.07), ODI (P=0.10), PCS (P=0.02), and MCS (P=0.06).Conclusion: The addition of a bone-anchored ACD following lumbar discectomy in patients with large post-surgical annular defects reduces the risk of reoperation and provides better long-term pain and disability relief over 4 years compared to lumbar discectomy only.Keywords: annular closure device, annulus fibrosus, disc herniation, lumbar discectomy, randomized controlled trial, reoperation, sciaticaNanda DArts MPMiller LEKöhler HPPerrin JMFlüh CVajkoczy PDove Medical Pressarticleannular closure deviceannulus fibrosusdisc herniationlumbar discectomyrandomized controlled trialreoperationsciaticaMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol Volume 12, Pp 327-335 (2019)
institution	DOAJ
collection	DOAJ
language	EN
topic	annular closure device annulus fibrosus disc herniation lumbar discectomy randomized controlled trial reoperation sciatica Medical technology R855-855.5
spellingShingle	annular closure device annulus fibrosus disc herniation lumbar discectomy randomized controlled trial reoperation sciatica Medical technology R855-855.5 Nanda D Arts MP Miller LE Köhler HP Perrin JM Flüh C Vajkoczy P Annular closure device lowers reoperation risk 4 years after lumbar discectomy
description	Dharmin Nanda1, Mark P Arts2, Larry E Miller3, Hans-Peter Köhler4, Jason M Perrin5, Charlotte Flüh6, Peter Vajkoczy7 1Department of Neurosurgery, Isala Klinieken, Zwolle, the Netherlands; 2Department of Neurosurgery, Haaglanden Medical Center Westeinde, The Hague, the Netherlands; 3Miller Scientific Consulting, Inc., Asheville, NC, USA; 4Department of Neurosurgery, Asklepios Westklinikum Hamburg, Hamburg, Germany; 5Department of Neurosurgery, University Clinic Mannheim, Mannheim, Germany; 6Department of Neurosurgery, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany; 7Department of Neurosurgery, Charité Universitätsmedizin, Berlin, GermanyCorrespondence: Dharmin NandaDepartment of Neurosurgery, Isala Klinieken, Dokter van Heesweg 2, AB Zwolle 8025, The NetherlandsTel +31 038 424 5000Email nanda@neurochirurgie-zwolle.nlObjective: To determine whether implanting an annular closure device (ACD) following a lumbar discectomy procedure in patients with large defects in the annulus fibrosus lowers the risk of reoperation after 4 years.Methods: In a multicenter randomized trial, patients with large annular defects following single-level lumbar discectomy were intraoperatively randomized to additionally receive an ACD or no treatment (Controls). Clinical and imaging follow-up were performed at routine intervals over 4 years of follow-up. Main outcomes included reoperations at the treated lumbar level, leg pain scores on a visual analog scale, Oswestry Disability Index (ODI), and Physical Component Summary (PCS) and Mental Component Summary (MCS) scores from the SF-36 questionnaire.Results: Among 550 patients (ACD 272, Control 278), the risk of reoperation over 4 years was 14.4% with ACD and 21.1% with Controls (P=0.03). The reduction in reoperation risk with ACD was not significantly influenced by patient age (P=0.51), sex (P=0.34), body mass index (P=0.21), smoking status (P=0.85), level of herniation (P=0.26), leg pain severity at baseline (P=0.90), or ODI at baseline (P=0.54). All patient-reported outcomes improved in each group from baseline to 4 years (all P<0.001). The percentage of patients who achieved the minimal clinically important difference without a reoperation was proportionally higher in the ACD group compared to Controls for leg pain (P=0.07), ODI (P=0.10), PCS (P=0.02), and MCS (P=0.06).Conclusion: The addition of a bone-anchored ACD following lumbar discectomy in patients with large post-surgical annular defects reduces the risk of reoperation and provides better long-term pain and disability relief over 4 years compared to lumbar discectomy only.Keywords: annular closure device, annulus fibrosus, disc herniation, lumbar discectomy, randomized controlled trial, reoperation, sciatica
format	article
author	Nanda D Arts MP Miller LE Köhler HP Perrin JM Flüh C Vajkoczy P
author_facet	Nanda D Arts MP Miller LE Köhler HP Perrin JM Flüh C Vajkoczy P
author_sort	Nanda D
title	Annular closure device lowers reoperation risk 4 years after lumbar discectomy
title_short	Annular closure device lowers reoperation risk 4 years after lumbar discectomy
title_full	Annular closure device lowers reoperation risk 4 years after lumbar discectomy
title_fullStr	Annular closure device lowers reoperation risk 4 years after lumbar discectomy
title_full_unstemmed	Annular closure device lowers reoperation risk 4 years after lumbar discectomy
title_sort	annular closure device lowers reoperation risk 4 years after lumbar discectomy
publisher	Dove Medical Press
publishDate	2019
url	https://doaj.org/article/fdb0d0356eb9442e8032da82c49dfa52
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Annular closure device lowers reoperation risk 4 years after lumbar discectomy

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