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A design with a stem in the humeral bone canal is currently regarded as the standard treatment option in patients who have an intact rotator cuff function, but complications related to the stem including humeral fractures can have devastating consequences. By using a stemless humeral component, stem-related complications can be reduced. The aim of this study is to compare the Comprehensive Nano stemless total shoulder arthroplasty (intervention group) with the Comprehensive stemmed total shoulder arthroplasty (control group).<\/jats:p><\/jats:sec><jats:sec><jats:title>Materials and methods<\/jats:title><jats:p>This is a randomized controlled trial comparing the stemless and the stemmed total shoulder arthroplasty. All Danish citizens with glenohumeral osteoarthritis indicating a total shoulder arthroplasty referred to the orthopedic department at Copenhagen University Hospital in Herlev\/Gentofte will be offered participation. The following exclude from participation: below 18\u2009years of age, cognitive or linguistic impairment, insufficient function of the rotator cuff, poor bone quality, and ASA groups 4\u20135. A total of 122 patients will be included of which 56 will be part of a radiostereometric analysis (RSA) study of humeral component migration. The primary outcomes are magnitude of migration of the humeral component assessed by RSA and patient-reported outcome by Western Ontario Osteoarthritis of the Shoulder index (WOOS). The secondary outcomes are additional patient-reported outcomes, functional outcome, readmission, complications, revisions, and changes in bone mineral density (BMD) of the proximal humerus assessed by duel energy x-ray absorptiometry (DXA) and economy (cost-utility analysis). The patients are examined before the operation and 3, 6, 12, and 24\u2009months postoperative.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>To our knowledge, RSA has never been used to access migration of a stemmed or a stemless humeral component nor has the stemmed and the stemless humeral component been compared with regard to pain relief and shoulder function in a randomized clinical trial. Today, the two designs are considered equal in the treatment of osteoarthritis. The study will provide surgeons and patients with information about shoulder arthroplasty for osteoarthritis and assist them in decision-making.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration<\/jats:title><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\/NCT04105478?id=NCT04105478&amp;draw=2&amp;rank=1&amp;load=cart\">NCT04105478<\/jats:ext-link>. Registered on 25 September 2019<\/jats:p><\/jats:sec>","DOI":"10.1186\/s13063-020-04763-8","type":"journal-article","created":{"date-parts":[[2020,10,7]],"date-time":"2020-10-07T09:05:57Z","timestamp":1602061557000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Early migration of stemless and stemmed humeral components after total shoulder arthroplasty for osteoarthritis\u2014study protocol for a randomized controlled trial"],"prefix":"10.1186","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5964-5602","authenticated-orcid":false,"given":"Marc Randall Kristensen","family":"Nyring","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bo S.","family":"Olsen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M\u00fcjgan","family":"Yilmaz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael M.","family":"Petersen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gunnar","family":"Flivik","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeppe V.","family":"Rasmussen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,10,7]]},"reference":[{"issue":"9","key":"4763_CR1","doi-asserted-by":"publisher","first-page":"1947","DOI":"10.2106\/00004623-200509000-00006","volume":"87","author":"D Bryant","year":"2005","unstructured":"Bryant D, Litchfield R, Sandow M, Gartsman GM, Guyatt G, Kirkley A. 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Available from: https:\/\/www.wma.net\/policies-post\/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects\/."}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-020-04763-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-020-04763-8\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-020-04763-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,11,22]],"date-time":"2022-11-22T11:17:01Z","timestamp":1669115821000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-020-04763-8"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,10,7]]},"references-count":50,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2020,12]]}},"alternative-id":["4763"],"URL":"https:\/\/doi.org\/10.1186\/s13063-020-04763-8","relation":{},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,10,7]]},"assertion":[{"value":"15 March 2020","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"22 September 2020","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"7 October 2020","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"The trial will be conducted according to the ethics outlined in the Helsinki Declaration []. All patients will receive oral and written information before they are asked to sign an informed consent form. The participating patient can withdraw their consent at any time.The Danish National Committee on Health Research Ethics has approved this study protocol (approval reference number <i>H-20017412 - H-19053566<\/i>), including the informed consent form and patient information sheets.The extra radiation dosage due to additional radiographic examinations in this study is 0.10\u2009mSv. The background radiation in Denmark is 3\u2009mSv each year. Therefore, the extra radiation dosage of 0.10\u2009mSv from this study corresponds to the background radiation during approximately 12\u2009days.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"One of the authors (BO) has previously given a paid lecture to the manufacturer, Zimmer Biomet, and one of the authors (MP) has previously received funding (institutional research support) for other investigator-initiated and industry-initiated research studies from Zimmer Biomet. However, Zimmer Biomet has not had any role in the design of the study and will not be involved in execution of the study or analysis or interpretation of study results and have no influence on the decision to submit the results for publication.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"830"}}