{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,30]],"date-time":"2026-05-30T03:00:07Z","timestamp":1780110007172,"version":"3.54.0"},"reference-count":31,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2020,6,8]],"date-time":"2020-06-08T00:00:00Z","timestamp":1591574400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2020,6,8]],"date-time":"2020-06-08T00:00:00Z","timestamp":1591574400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"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>Intraarticular distal humeral fractures of AO\/OTA type 13 C2 and C3 pose a surgical challenge despite the evolution of surgical implants and techniques. Open reduction and internal fixation (ORIF) is often preferred as the first choice of treatment, but the results vary and are sometimes disappointing. Total elbow arthroplasty (TEA) has been widely used for fractures that are not amenable to ORIF in elderly patients, but the mechanical complications remain a challenge, especially in active patients. Elbow hemiarthroplasty (EHA) provides a modern alternative that might avoid the mechanical complications and weight bearing restrictions related to the linked articulation in semi-constrained TEA. No studies have compared the results of EHA to that of ORIF, but case series have reported promising results.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Methods\/design<\/jats:title>\n<jats:p>This is a study protocol describing an investigator-initiated, non-blinded randomized controlled trial comparing the outcome of EHA with ORIF for AO\/OTA type 13 C2 and C3 fractures of the distal humerus in patients who are 50\u2009years or older. Forty-four patients with AO\/OTA type 13 C2 and C3 fractures of distal humerus will be randomized to either EHA or ORIF. The Oxford Elbow Score (OES) will be used as primary outcome. Mayo Elbow Performance Score (MEPS), pain severity score (VAS), range of motion, and patient satisfaction will be used as secondary outcomes. Reoperations, complications, and the length of sick leave will be recorded. The patients will be examined after the operation and at 3\u2009months and 1, 2, 5, and 10\u2009years.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Discussion<\/jats:title>\n<jats:p>The main objective of this study is to investigate the best treatment option for AO\/OTA type 13 C2 and C3 fractures of distal humerus in patients aged 50\u2009years or above. We hypothesize that EHA results in fewer complications and superior functional outcome compared with ORIF and that the mechanical complications related to the linked articulation of TEA can be avoided.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Trial registration<\/jats:title>\n<jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>, PRS, <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/study\/NCT04163172\">NCT04163172<\/jats:ext-link>. Registered November 13, 2019. <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/results?cond=&amp;term=evori&amp;cntry=&amp;state=&amp;city=&amp;dist=\">https:\/\/clinicaltrials.gov\/ct2\/results?cond=&amp;term=evori&amp;cntry=&amp;state=&amp;city=&amp;dist=<\/jats:ext-link> (Table\u00a02).<\/jats:p>\n<jats:p>The protocol has been approved by The Scientific Ethics Committee of the Capital Region of Denmark (Jr. no.: H<jats:sup>\u2212\u200919,035,590<\/jats:sup>).<\/jats:p>\n<jats:p>The processing of personal data has been approved by the Danish Data Protection Agency (Jr. no. P-2019-246). Inclusion started on February 1, 2020.<\/jats:p>\n<\/jats:sec>","DOI":"10.1186\/s13063-020-04418-8","type":"journal-article","created":{"date-parts":[[2020,6,8]],"date-time":"2020-06-08T09:05:57Z","timestamp":1591607157000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Elbow hemiarthroplasty versus open reduction and internal fixation for AO\/OTA type 13 C2 and C3 fractures of distal humerus in patients aged 50\u2009years or above: a randomized controlled trial"],"prefix":"10.1186","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5562-2737","authenticated-orcid":false,"given":"Ali","family":"Al-Hamdani","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeppe V.","family":"Rasmussen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenneth","family":"Holtz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bo S.","family":"Olsen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,6,8]]},"reference":[{"key":"4418_CR1","doi-asserted-by":"publisher","unstructured":"Al-Hamdani A, Rasmussen JV, S\u00f8rensen AKB, Ovesen J, Holtz K, Brorson S, Olsen BS. 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The processing of personal data has been approved by the Danish Data Protection Agency (Jr. no. P-2019-246). All patients will receive oral and written information before they are asked to sign an informed consent form. If the patients agree to participate, they will then be asked to sign the informed consent form. They will also receive a folder with patient participant information and \u201cParticipants\u2019 rights in a health science research project\u201d folder. The participating patients can withdraw their consent at any time. The Study will follow the Helsinki Declaration. All patients included in the study are covered by the insurance policies that apply to ordinary treatment in the hospital, and they may complain and receive compensation following the rules in the Act on Complaints and Compensation in the Health Services in Denmark.The standard treatment at our department includes preoperative planning with plain radiographs and CT of the injured elbow joint and follow-up examinations with plain radiographs postoperatively and at 3\u2009months. In addition to this standard treatment, the participating patients will have additional clinical radiographic examinations, including plain radiographs at 1, 2, 5, and 10\u2009years. The extra radiation dosage from this study is 0.0116\u2009mSv, which corresponds to the background radiation during approximately one and a half days.","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":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"497"}}