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There is much debate on which treatment (operative or non-operative) is best for the individual patient. In order to give a more personalized recommendation we aim to evaluate the effectiveness and cost-effectiveness of a treatment algorithm for patients with a complete primary ACL rupture.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>The ROTATE-trial is a multicenter, open-labeled cluster randomized controlled trial with superiority design. Randomization will take place on hospital level (<jats:italic>n<\/jats:italic>\u2009=\u200910). Patients must meet all the following criteria: aged 18\u2009year or older, with a complete primary ACL rupture (confirmed by MRI and physical examination) and maximum of 6\u2009weeks of non-operative treatment. Exclusion criteria consists of multi ligament trauma indicated for surgical intervention, presence of another disorder that affects the activity level of the lower limb, pregnancy, and insufficient command of the Dutch language. The intervention to be investigated will be an adjusted treatment decision strategy, including an advice from our treatment algorithm. Patient reported outcomes will be conducted at baseline, 3, 6, 12 and 24\u2009months. Physical examination of the knee at baseline, 12 and 24\u2009months. Primary outcome will be function of the knee measured by the International Knee Documentation Committee (IKDC) questionnaire. Secondary outcomes are, among others, the Tegner activity score, the Knee injury and Osteoarthritis Outcome Score (KOOS) and the 9-item Shared Decision Making Questionnaire (SDM-Q-9). Healthcare use, productivity and satisfaction with ((non-)operative) care are also measured by means of questionnaires. In total 230 patients will be included, resulting in 23 patients per hospital.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>The ROTATE study aims to evaluate the effectiveness and cost-effectiveness of a treatment algorithm for patients with a complete primary ACL rupture compared to current used treatment strategy. Using a treatment algorithm might give the much-wanted personalized treatment recommendation.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>This study is approved by the Medical Research Ethics Committee of Erasmus Medical Center in Rotterdam and prospectively registered at the Dutch Trial Registry on May 13th, 2020. Registration number: NL8637.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12891-021-04867-5","type":"journal-article","created":{"date-parts":[[2022,2,5]],"date-time":"2022-02-05T16:02:44Z","timestamp":1644076964000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Study protocol ROTATE-trial: anterior cruciate ligament rupture, the influence of a treatment algorithm and shared decision making on clinical outcome\u2013 a cluster randomized controlled trial"],"prefix":"10.1186","volume":"23","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5803-9782","authenticated-orcid":false,"given":"Floris H.","family":"de Vos","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Duncan E.","family":"Meuffels","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marleen","family":"de Mul","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marjan","family":"Askari","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Erwin","family":"Ista","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Suzanne","family":"Polinder","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Erwin","family":"Waarsing","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sita M.","family":"Bierma-Zeinstra","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Max","family":"Reijman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"on behalf of the ROTATE study group","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"E. 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All participants signed an informed consent form prior to start of the study. The trial is registered in the Dutch Trial Registry (registration number NL8637). In all participating hospitals, the local responsible authorities approved the conduct of the study. In case of important protocol modifications (e.g. new or cancelling of a recruiting hospital, change in outcomes) this will be communicated toward the Medical Research Ethics Committee.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"No individual person\u2019s data will be published, therefore consent for publication is not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"117"}}