{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,4]],"date-time":"2025-05-04T04:08:25Z","timestamp":1746331705279},"reference-count":44,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2017,5,24]],"date-time":"2017-05-24T00:00:00Z","timestamp":1495584000000},"content-version":"vor","delay-in-days":23,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Orthopaedic Surgery"],"published-print":{"date-parts":[[2017,5]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>To investigate the clinical feasibility and validity of interspinous fastener (<jats:styled-content style=\"fixed-case\">ISF<\/jats:styled-content>) for lumbar degenerative diseases.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>From October 2013 to March 2014, a total of 46 patients suffering from lumbar degenerative diseases underwent posterior lumbar interbody fusion (<jats:styled-content style=\"fixed-case\">PLIF<\/jats:styled-content>) randomly augmented by <jats:styled-content style=\"fixed-case\">ISF<\/jats:styled-content> or pedicle screws. The clinical outcome was primarily measured by Oswestry Disability Index (<jats:styled-content style=\"fixed-case\">ODI<\/jats:styled-content>) score. The minimal clinical important difference (<jats:styled-content style=\"fixed-case\">MCID<\/jats:styled-content>) was defined as an eight\u2010point decrease in <jats:styled-content style=\"fixed-case\">ODI<\/jats:styled-content>. The second clinical outcome measurement was Japanese Orthopedic Association (<jats:styled-content style=\"fixed-case\">JOA<\/jats:styled-content>) score. Interbody fusion rates were evaluated by lumbar plain radiograph and computed tomography (<jats:styled-content style=\"fixed-case\">CT<\/jats:styled-content>) scan. Complications were also compared between groups. Statistical analyses were performed by <jats:styled-content style=\"fixed-case\">SPSS<\/jats:styled-content> version 13.0. Sample size calculation was performed before the study. The type I error \u03b1 was set at 0.05 and the type <jats:styled-content style=\"fixed-case\">II<\/jats:styled-content> error \u03b2 at 0.1. Based on these assumptions and adding 10% for possible drop\u2010outs, sample size calculations indicated that a total of 46 patients were required for the study. Parametric data was compared by independent <jats:italic>t<\/jats:italic>\u2010test and categorical variables were compared using \u03c7<jats:sup>2<\/jats:sup>\u2010tests or Fisher exact tests depending on the sample size. A <jats:italic>P<\/jats:italic>\u2010value of less than 0.05 was considered significantly statistically different. Fleiss kappa coefficients were calculated for intra\u2010observer and inter\u2010observer reliability.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 43 patients completed the follow\u2010up, with 22 cases in the <jats:styled-content style=\"fixed-case\">ISF<\/jats:styled-content> group and 21 patients in the pedicle screws group, respectively. Less intraoperative blood loss and shorter operation time were observed in the <jats:styled-content style=\"fixed-case\">ISF<\/jats:styled-content> group. The mean <jats:styled-content style=\"fixed-case\">ODI<\/jats:styled-content> significantly declined in both groups, with the <jats:styled-content style=\"fixed-case\">ISF<\/jats:styled-content> group's decreasing from preoperative 43.3 \u00b1 8.2 to 21.4 \u00b1 3.5 at 24\u2010month follow\u2010up and the pedicle screws group's decreasing from preoperative 42.9 \u00b1 7.9 to 22.5 \u00b13.8 at 24\u2010month follow\u2010up, respectively. The <jats:styled-content style=\"fixed-case\">ODI<\/jats:styled-content> changes between groups had no statistical difference (<jats:italic>P<\/jats:italic> &gt; 0.05). Of the 43 patients, 33 patients achieved an <jats:styled-content style=\"fixed-case\">MCID<\/jats:styled-content>. The bone fusion rate was 77.3% according to X\u2010rays and 68.2% according to <jats:styled-content style=\"fixed-case\">CT<\/jats:styled-content> scans in the <jats:styled-content style=\"fixed-case\">ISF<\/jats:styled-content> group, and 81.0% according to X\u2010rays and 76.2% according to <jats:styled-content style=\"fixed-case\">CT<\/jats:styled-content> scans in the pedicle screws group at the final follow\u2010up. The intra\u2010observer and inter\u2010observer reliability assessed by the kappa value were 0.93 and 0.89, respectively. One patient in the pedicle screws group demonstrated screw loosening at the 6\u2010month follow\u2010up but was asymptomatic. One patient with spondylolisthesis in the <jats:styled-content style=\"fixed-case\">ISF<\/jats:styled-content> group demonstrated cage subsidence during the follow\u2010up but also without related symptoms.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The less invasive <jats:styled-content style=\"fixed-case\">ISF<\/jats:styled-content> combined with <jats:styled-content style=\"fixed-case\">PLIF<\/jats:styled-content> provided comparable clinical outcome and a similar bone fusion rate to pedicle screws. The <jats:styled-content style=\"fixed-case\">ISF<\/jats:styled-content> could potentially serve as a new alternative for lumbar degenerative diseases.<\/jats:p><\/jats:sec>","DOI":"10.1111\/os.12328","type":"journal-article","created":{"date-parts":[[2017,5,25]],"date-time":"2017-05-25T16:42:31Z","timestamp":1495730551000},"page":"198-205","source":"Crossref","is-referenced-by-count":6,"title":["Posterior Lumbar Interbody Fusion with Interspinous Fastener Provides Comparable Clinical Outcome and Fusion Rate to Pedicle Screws"],"prefix":"10.1111","volume":"9","author":[{"given":"Wei\u2010min","family":"Huang","sequence":"first","affiliation":[{"name":"Department of Orthopaedics General Hospital of Jinan Military Commanding Region  Jinan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xing\u2010ming","family":"Yu","sequence":"additional","affiliation":[{"name":"Postgraduate Training Base in General Hospital of Jinan Military Command Liaoning Medical University  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