@article{rayyan-216966807,
  title={Annular closure device lowers reoperation risk 4 years after lumbar discectomy.},
  year={2019},
  journal={Medical devices (Auckland, N.Z.)},
  issn={1179-1470 (Print)},
  volume={12},
  pages={327-335},
  author={Nanda D and Arts MP and Miller LE and Köhler HP and Perrin JM and Flüh C and Vajkoczy P},
  institution={Department of Neurosurgery, Isala Klinieken, Zwolle, the Netherlands.; Department of Neurosurgery, Haaglanden Medical Center Westeinde, The Hague, the Netherlands.; Miller Scientific Consulting, Inc., Asheville, NC, USA.; Department of Neurosurgery, Asklepios Westklinikum Hamburg, Hamburg, Germany.; Department of Neurosurgery, University Clinic Mannheim, Mannheim, Germany.; Department of Neurosurgery, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany.; Department of Neurosurgery, Charité Universitätsmedizin, Berlin, Germany.},
  url={https://pubmed.ncbi.nlm.nih.gov/31564999/},
  language={eng},
  keywords={Reoperation, Diskectomy},
  abstract={OBJECTIVE: 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.},
  note={ RAYYAN-INCLUSION: {"Laia"=>"Included"} | RAYYAN-LABELS: Barricaid}
}

{"_id":"PDzuEJyYBHnpBSz6i","bibbaseid":"d-mp-le-hp-jm-c-p-annularclosuredevicelowersreoperationrisk4yearsafterlumbardiscectomy-2019","author_short":["D, N.","MP, A.","LE, M.","HP, K.","JM, P.","C, F.","P, V."],"bibdata":{"bibtype":"article","type":"article","title":"Annular closure device lowers reoperation risk 4 years after lumbar discectomy.","year":"2019","journal":"Medical devices (Auckland, N.Z.)","issn":"1179-1470 (Print)","volume":"12","pages":"327-335","author":[{"firstnames":["Nanda"],"propositions":[],"lastnames":["D"],"suffixes":[]},{"firstnames":["Arts"],"propositions":[],"lastnames":["MP"],"suffixes":[]},{"firstnames":["Miller"],"propositions":[],"lastnames":["LE"],"suffixes":[]},{"firstnames":["Köhler"],"propositions":[],"lastnames":["HP"],"suffixes":[]},{"firstnames":["Perrin"],"propositions":[],"lastnames":["JM"],"suffixes":[]},{"firstnames":["Flüh"],"propositions":[],"lastnames":["C"],"suffixes":[]},{"firstnames":["Vajkoczy"],"propositions":[],"lastnames":["P"],"suffixes":[]}],"institution":"Department of Neurosurgery, Isala Klinieken, Zwolle, the Netherlands.; Department of Neurosurgery, Haaglanden Medical Center Westeinde, The Hague, the Netherlands.; Miller Scientific Consulting, Inc., Asheville, NC, USA.; Department of Neurosurgery, Asklepios Westklinikum Hamburg, Hamburg, Germany.; Department of Neurosurgery, University Clinic Mannheim, Mannheim, Germany.; Department of Neurosurgery, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany.; Department of Neurosurgery, Charité Universitätsmedizin, Berlin, Germany.","url":"https://pubmed.ncbi.nlm.nih.gov/31564999/","language":"eng","keywords":"Reoperation, Diskectomy","abstract":"OBJECTIVE: 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.","note":"RAYYAN-INCLUSION: \"Laia\"=>\"Included\" | RAYYAN-LABELS: Barricaid","bibtex":"@article{rayyan-216966807,\n title={Annular closure device lowers reoperation risk 4 years after lumbar discectomy.},\n year={2019},\n journal={Medical devices (Auckland, N.Z.)},\n issn={1179-1470 (Print)},\n volume={12},\n pages={327-335},\n author={Nanda D and Arts MP and Miller LE and Köhler HP and Perrin JM and Flüh C and Vajkoczy P},\n institution={Department of Neurosurgery, Isala Klinieken, Zwolle, the Netherlands.; Department of Neurosurgery, Haaglanden Medical Center Westeinde, The Hague, the Netherlands.; Miller Scientific Consulting, Inc., Asheville, NC, USA.; Department of Neurosurgery, Asklepios Westklinikum Hamburg, Hamburg, Germany.; Department of Neurosurgery, University Clinic Mannheim, Mannheim, Germany.; Department of Neurosurgery, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany.; Department of Neurosurgery, Charité Universitätsmedizin, Berlin, Germany.},\n url={https://pubmed.ncbi.nlm.nih.gov/31564999/},\n language={eng},\n keywords={Reoperation, Diskectomy},\n abstract={OBJECTIVE: 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.},\n note={ RAYYAN-INCLUSION: {\"Laia\"=>\"Included\"} | RAYYAN-LABELS: Barricaid}\n}\n\n","author_short":["D, N.","MP, A.","LE, M.","HP, K.","JM, P.","C, F.","P, V."],"key":"rayyan-216966807","id":"rayyan-216966807","bibbaseid":"d-mp-le-hp-jm-c-p-annularclosuredevicelowersreoperationrisk4yearsafterlumbardiscectomy-2019","role":"author","urls":{"Paper":"https://pubmed.ncbi.nlm.nih.gov/31564999/"},"keyword":["Reoperation","Diskectomy"],"metadata":{"authorlinks":{}},"html":""},"bibtype":"article","biburl":"https://bibbase.org/f/TPGPL5RdqzSukDwSi/uploaded.bib","dataSources":["6XFwdKFq8ZPpPwgbg","ogsnK2C2pT8oeZoHD"],"keywords":["reoperation","diskectomy"],"search_terms":["annular","closure","device","lowers","reoperation","risk","years","lumbar","discectomy","d","mp","le","hp","jm","c","p"],"title":"Annular closure device lowers reoperation risk 4 years after lumbar discectomy.","year":2019}