{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T13:21:48Z","timestamp":1740144108520,"version":"3.37.3"},"reference-count":25,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2020,9,10]],"date-time":"2020-09-10T00:00:00Z","timestamp":1599696000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2020,9,10]],"date-time":"2020-09-10T00:00:00Z","timestamp":1599696000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100008894","name":"Stryker","doi-asserted-by":"publisher","award":["241382"],"award-info":[{"award-number":["241382"]}],"id":[{"id":"10.13039\/100008894","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"published-print":{"date-parts":[[2020,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Robotic-arm assisted surgery aims to reduce manual errors and improve the accuracy of implant positioning during total hip arthroplasty. The objective of this study is to compare the accuracy of implant positioning, restoration of hip biomechanics, patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications in conventional manual total hip arthroplasty (CO THA) versus robotic-arm assisted total hip arthroplasty (RO THA). Preoperative pelvic computerised tomography (CT) scans will be used to create patient-specific, virtual, three-dimensional reconstructions for surgical planning in both treatment groups.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods and analysis<\/jats:title>\n                <jats:p>This prospective randomised controlled trial will include 60 patients with symptomatic hip osteoarthritis undergoing primary THA. Following informed consent, patients will be randomised to CO THA (control group) or RO THA (investigation group) at a ratio of 1:1 using an online random number generator. Observers will review patients at regular intervals for 2\u00a0years after surgery to record predefined study outcomes relating to the accuracy of implant positioning, hip biomechanics, postoperative rehabilitation, clinical progress, functional outcomes, cost-effectiveness, and complications. Primary and secondary objectives will be used to quantify and draw inferences on differences in the efficacy of treatment between the two groups. Intention-to-treat and per-protocol population analysis will be undertaken. Intention to treat relates to the allocated treatment (CO THA or RO THA), and per-protocol refers to the actual treatment received by the patient. The following statistical methods will be employed to analyse the data: descriptive statistics, independent <jats:italic>t<\/jats:italic> test, paired <jats:italic>t<\/jats:italic> test, analysis of variance, Fisher exact test, chi-square test, and graphical displays. Ethical approval was obtained from the London-Bromley Research Ethics Committee, UK. The study is sponsored by University College London, UK.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>This study compares a comprehensive and robust range of clinical, functional, and radiological outcomes in CT-planned CO THA versus CT-planned RO THA. The findings of this study will enable an improved understanding of the differences in CO THA versus RO THA with respect to patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>ClinicalTrials.gov <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04095845?cond=mako&amp;draw=2&amp;rank=7\">NCT04095845<\/jats:ext-link>. Registered on 19 September 2019<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13063-020-04702-7","type":"journal-article","created":{"date-parts":[[2020,9,10]],"date-time":"2020-09-10T07:03:46Z","timestamp":1599721426000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Computerised tomography-based planning with conventional total hip arthroplasty versus robotic-arm assisted total hip arthroplasty: study protocol for a prospective randomised controlled trial"],"prefix":"10.1186","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6611-3989","authenticated-orcid":false,"given":"Babar","family":"Kayani","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sujith","family":"Konan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jenni","family":"Tahmassebi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Atif","family":"Ayuob","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fares S.","family":"Haddad","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2020,9,10]]},"reference":[{"key":"4702_CR1","unstructured":"No authors listed. 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Consent to use the data collected for scientific reporting and publication will also be obtained at the same time as the consent to participate.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"The findings of this research will be published in peer-reviewed journals. All study patients will provide informed consent for the publication of anonymised patient data and study findings. Authorship will reflect the amount of time spent designing the study, collating the data, analysing the results, and writing the manuscript. No professional writers will be used. All study patients will receive a lay summary of the pertinent findings from the study.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"FSH reports board membership of the <i>Bone and Joint Journal<\/i> and the <i>Annals of the Royal College of Surgeons<\/i>; consultancy for Smith & Nephew, Corin, MatOrtho and Stryker; payment for lectures including service on speakers\u2019 bureaus for Smith & Nephew and Stryker; and royalties paid by Smith & Nephew, MatOrtho, Corin and Stryker, all outside the submitted work.SK reports consultancy, payment for lectures including service on speakers\u2019 bureaus, and payment for development of education presentations and travel\/accommodations\/meeting expenses for Smith and Nephew and AO, all outside the submitted work.All other authors declare no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"776"}}