{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,10]],"date-time":"2026-02-10T20:05:37Z","timestamp":1770753937342,"version":"3.50.0"},"reference-count":12,"publisher":"Public Library of Science (PLoS)","issue":"9","license":[{"start":{"date-parts":[[2023,9,8]],"date-time":"2023-09-08T00:00:00Z","timestamp":1694131200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008894","name":"Stryker","doi-asserted-by":"publisher","award":["Luzerner Katonsspital T-I-101"],"award-info":[{"award-number":["Luzerner Katonsspital T-I-101"]}],"id":[{"id":"10.13039\/100008894","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Background<\/jats:title>\n<jats:p>Single plate osteosynthesis is commonly employed when performing surgical stabilization of midshaft clavicle fractures. In recent years, a smaller structural low-profile double plating technique has been described as a possible solution for the high removal rates associated with single plating. A previous meta-analysis has demonstrated that low-profile double plating attains the same healing rates as single plating without a higher chance of fracture-related infections. This meta-analysis, however, was based on relatively small studies. Therefore, a multicentre prospective natural experiment was designed using natural variation in treatment regimens and geographical location of the trauma as treatment allocation mechanism to compare both treatments on a larger scale. This manuscript describes its protocol.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Material &amp; methods<\/jats:title>\n<jats:p>Patients (\u226516 years) with primary midshaft clavicle fractures that are eligible for operative treatment will be included. Treatment allocation will be determined by the geographical location of the accident and local hospital providing treatment. In two centres, single plating is the treatment of choice for these patients. In two others, low-profile double plating has become the standard treatment. For the low-profile double plating group, one superiorly positioned VariAx 2.0mm and one anterior VariAx 2.4mm or 2.7mm plate will be used. For the single plating group, the standard locally available implant will be used. A total of 336 patients will be included. The primary outcome of interest is re-intervention. Secondary outcomes include complications, operative time, length of incision, functional scores (DASH, EQ-5D-DL, VAS-Pain\/Satisfaction) and cost-effectiveness.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Discussion<\/jats:title>\n<jats:p>This study will determine whether low-profile double plating has significant clinical and cost-effective benefits over single plating techniques in midshaft clavicle fractures. The study will also give insight in the performance of a natural experiment study design for orthopedic trauma research.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>Trial registration<\/jats:title>\n<jats:p>This study has been registered on ClincialTrials.gov, identifier <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT05579873\" xlink:type=\"simple\">NCT 05579873<\/jats:ext-link>.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0291238","type":"journal-article","created":{"date-parts":[[2023,9,8]],"date-time":"2023-09-08T17:55:26Z","timestamp":1694195726000},"page":"e0291238","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":5,"title":["A natural experiment study: Low-profile double plating versus single plating techniques in midshaft clavicle fractures\u2014Study protocol"],"prefix":"10.1371","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2291-8272","authenticated-orcid":true,"given":"Yannic","family":"Lecoultre","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bryan J. M.","family":"van de Wall","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nadine","family":"Diwersi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Steffen W.","family":"Pfarr","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Beat","family":"Galliker","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Reto","family":"Babst","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bj\u00f6rn-Christian","family":"Link","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frank J. P.","family":"Beeres","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2023,9,8]]},"reference":[{"key":"pone.0291238.ref001","doi-asserted-by":"crossref","first-page":"423","DOI":"10.1016\/j.jse.2011.08.053","article-title":"Treatment of clavicle fractures: current concepts review.","volume":"21","author":"OA van der Meijden","year":"2012","journal-title":"J shoulder Elb Surg."},{"key":"pone.0291238.ref002","doi-asserted-by":"crossref","first-page":"452","DOI":"10.1067\/mse.2002.126613","article-title":"Epidemiology of clavicle fractures.","volume":"11","author":"F Postacchini","year":"2002","journal-title":"J shoulder Elb Surg."},{"key":"pone.0291238.ref003","doi-asserted-by":"crossref","first-page":"e468","DOI":"10.5435\/JAAOS-D-17-00442","article-title":"Management of Midshaft Clavicle Fractures in Adults.","volume":"26","author":"B Wiesel","year":"2018","journal-title":"J Am Acad Orthop Surg."},{"key":"pone.0291238.ref004","doi-asserted-by":"crossref","first-page":"617","DOI":"10.1007\/s00402-011-1456-5","article-title":"Systematic review of the complications of plate fixation of clavicle fractures.","volume":"132","author":"FJG Wijdicks","year":"2012","journal-title":"Arch Orthop Trauma Surg"},{"key":"pone.0291238.ref005","doi-asserted-by":"crossref","first-page":"647","DOI":"10.1016\/j.injury.2020.01.014","article-title":"Safety and efficacy of using 2.4\/2.4 mm and 2.0\/2.4 mm dual mini-fragment plate combinations for fixation of displaced diaphyseal clavicle fractures.","volume":"51","author":"MJ Chen","year":"2020","journal-title":"Injury"},{"key":"pone.0291238.ref006","doi-asserted-by":"crossref","first-page":"148","DOI":"10.1186\/s13018-020-01666-x","article-title":"Finite element analysis of dual small plate fixation and single plate fixation for treatment of midshaft clavicle fractures.","volume":"15","author":"F Zhang","year":"2020","journal-title":"J Orthop Surg Res."},{"key":"pone.0291238.ref007","doi-asserted-by":"crossref","first-page":"3063","DOI":"10.1007\/s00068-021-01845-3","article-title":"Low profile dual plating for mid-shaft clavicle fractures: a meta-analysis and systematic review of observational studies","volume":"48","author":"IF Rompen","year":"2022","journal-title":"Eur J Trauma Emerg Surg"},{"key":"pone.0291238.ref008","doi-asserted-by":"crossref","first-page":"429","DOI":"10.1016\/j.injury.2022.11.028","article-title":"Natural experiments for orthopaedic trauma research: An introduction.","volume":"54","author":"BJM van de Wall","year":"2023","journal-title":"Injury"},{"key":"pone.0291238.ref009","doi-asserted-by":"crossref","first-page":"S1","DOI":"10.1097\/BOT.0000000000001063","article-title":"Fracture and Dislocation Classification Compendium-2018.","volume":"321","author":"EG Meinberg","year":"2018","journal-title":"J Orthop Trauma."},{"key":"pone.0291238.ref010","doi-asserted-by":"crossref","first-page":"505","DOI":"10.1016\/j.injury.2017.08.040","article-title":"Fracture-related infection: A consensus on definition from an international expert group.","volume":"49","author":"WJ Metsemakers","year":"2018","journal-title":"Injury."},{"key":"pone.0291238.ref011","doi-asserted-by":"crossref","first-page":"1986","DOI":"10.1016\/j.injury.2019.08.004","article-title":"Absolute or relative stability in plate fixation for simple humeral shaft fractures.","volume":"50","author":"BJM van de Wall","year":"2019","journal-title":"Injury"},{"key":"pone.0291238.ref012","doi-asserted-by":"crossref","first-page":"187","DOI":"10.1097\/SLA.0b013e3181b13ca2","article-title":"The Clavien-Dindo classification of surgical complications: five-year experience","volume":"250","author":"PA Clavien","year":"2009","journal-title":"Ann Surg"}],"container-title":["PLOS ONE"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0291238","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,8]],"date-time":"2023-09-08T17:55:36Z","timestamp":1694195736000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0291238"}},"subtitle":[],"editor":[{"given":"Hans-Peter","family":"Simmen","sequence":"first","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2023,9,8]]},"references-count":12,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2023,9,8]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0291238","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,9,8]]}}}