{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,25]],"date-time":"2026-07-25T04:04:33Z","timestamp":1784952273499,"version":"3.55.0"},"reference-count":26,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,2,3]],"date-time":"2024-02-03T00:00:00Z","timestamp":1706918400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,2,3]],"date-time":"2024-02-03T00:00:00Z","timestamp":1706918400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"ELSAN Comit\u00e9 Orientation Scientifique"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Robotic spinal surgery may result in better pedicle screw placement accuracy, and reduction in radiation exposure and length of stay, compared to freehand surgery. The purpose of this randomized controlled trial (RCT) is to compare screw placement accuracy of robot-assisted surgery with integrated 3D computer-assisted navigation versus freehand surgery with 2D fluoroscopy for arthrodesis of the thoraco-lumbar spine.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>This is a single-centre evaluator-blinded RCT with a 1:1 allocation ratio. Participants (<jats:italic>n<\/jats:italic> = 300) will be randomized into two groups, robot-assisted (Mazor X Stealth Edition) versus freehand, after stratification based on the planned number of pedicle screws needed for surgery. The primary outcome is the proportion of pedicle screws placed with grade A accuracy (Gertzbein-Robbins classification) on postoperative computed tomography images. The secondary outcomes are intervention time, operation room occupancy time, length of stay, estimated blood loss, surgeon\u2019s radiation exposure, screw fracture\/loosening, superior-level facet joint violation, complication rate, reoperation rate on the same level or one level above, functional and clinical outcomes (Oswestry Disability Index, pain, Hospital Anxiety and Depression Scale, sensory and motor status) and cost-utility analysis.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>This RCT will provide insight into whether robot-assisted surgery with the newest generation spinal robot yields better pedicle screw placement accuracy than freehand surgery. Potential benefits of robot-assisted surgery include lower complication and revision rates, shorter length of stay, lower radiation exposure and reduction of economic cost of the overall care.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>ClinicalTrials.gov NCT05553028. Registered on September 23, 2022<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13063-024-07908-1","type":"journal-article","created":{"date-parts":[[2024,2,3]],"date-time":"2024-02-03T06:02:09Z","timestamp":1706940129000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Pedicle screw placement accuracy in robot-assisted versus image-guided freehand surgery of thoraco-lumbar spine (ROBARTHRODESE): study protocol for a single-centre randomized controlled trial"],"prefix":"10.1186","volume":"25","author":[{"given":"Nicolas","family":"Aurouer","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Guerin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arnaud","family":"Cogniet","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolas","family":"Gangnet","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Morad","family":"Pedram","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pierre-Thierry","family":"Piechaud","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"ReSurg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacobus H.","family":"Muller","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mo","family":"Saffarini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sonia","family":"Ramos-Pascual","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kinga","family":"Michalewska","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo","family":"Mangione","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,2,3]]},"reference":[{"issue":"Suppl 1","key":"7908_CR1","doi-asserted-by":"publisher","first-page":"S31","DOI":"10.21037\/jss.2019.04.16","volume":"5","author":"BN Staub","year":"2019","unstructured":"Staub BN, Sadrameli SS. 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The research is conducted in accordance with this protocol, except in emergency situations requiring the implementation of specific therapeutic acts. The investigating surgeons will respect all aspects of the protocol, in particular, with regard to the collection of consent and notification and follow-up of SAEs. The present study was approved by the committee I Sud-M\u00e9diterran\u00e9e of the CPP (2022-A00874-39) on 12\/08\/2022.The patient will be informed orally and in writing through the information note about the objective of the research; the progress and duration of the study; the benefits, potential risks and constraints of the study; and the opinion given by the CPP (art. L.1122-1 CSP). The information note is supplemented with the information necessary to comply with the regulations on the protection of personal data (GDPR). The investigating surgeon must specify to the patient that they are totally free to accept or refuse their participation in the research and that they retain the right to withdraw from the study at any time for any reason without causing any prejudice, in particular, professional one. The patient\u2019s participation in the protocol will be mentioned in their medical file at the time of the inclusion visit. All patients will provide written informed consent signifying their agreement to participate in the research before any study-specific assessment or procedure is performed (Art.L1122-1-1 CSP). No compensation is provided for the participation in this study.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate {24}"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication {32}"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests {28}"}}],"article-number":"106"}}