{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T04:26:42Z","timestamp":1772166402318,"version":"3.50.1"},"reference-count":40,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2020,7,2]],"date-time":"2020-07-02T00:00:00Z","timestamp":1593648000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2020,7,2]],"date-time":"2020-07-02T00:00:00Z","timestamp":1593648000000},"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>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Ankle sprains and fractures are most common injuries in orthopedic and trauma surgery. The concurrent occurrence of syndesmosis ruptures in these injuries represents a more complex problem, as they often remain undetected.<\/jats:p>\n                    <jats:p>A proper and accurate treatment of injuries of the syndesmosis, both isolated and combined with fractures, is necessary to avoid long-term consequences (chronic instability, cartilage damage, and post-traumatic osteoarthritis). The most popular treatment option is a static screw fixation and the newly developed dynamic TightRope\u00ae (Arthrex, Naples, FL, USA).<\/jats:p>\n                    <jats:p>The aim of this pilot study is to compare monitor ankle range of motion and maximum ankle power in gait as functional outcome parameters of instrumented gait analysis, as well as clinical and radiographic outcome for assessing the stabilization of acute syndesmosis rupture with either a static implant (a 3.5\u2009mm metallic screw) or a dynamic device (TightRope\u00ae).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This prospective, randomized, controlled, clinical trial will be carried out at the Center for Orthopedics, Trauma Surgery and Spinal Cord Injury of the University Hospital Heidelberg. Adult patients, who suffer from an acute syndesmosis rupture, both isolated and in combination with fractures of the lateral malleolus (Weber C and Maisonneuve fractures) and who are undergoing surgery at our trauma center will be included in our study. The patients will be randomized to the different treatment options (screw fixation or \u201cTightRope\u00ae\u201d). Subsequent to the surgical treatment, all patients will receive the same standardized follow-up procedures including a gait analysis and MRI of the ankle at 6\u2009months follow-up.<\/jats:p>\n                    <jats:p>The primary endpoint of the study is the successful healing of the syndesmosis and biomechanical investigation with gait analysis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>The results of the gait analysis from the current study will help to impartially and reliably evaluate the clinical and biomechanical outcome of both treatment options of acute syndesmosis ruptures. We hypothesize that the dynamic fixation provides an equivalent or better biomechanical, clinical, and radiographic outcome in comparison to the screw fixation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      German Clinical Trials Register (DRKS)\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.drks.de\/drks_web\/navigate.do?navigationId=trial.HTML&amp;TRIAL_ID=DRKS00013562\">DRKS00013562<\/jats:ext-link>\n                      . Registered on July, 12, 2017.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-020-04550-5","type":"journal-article","created":{"date-parts":[[2020,7,2]],"date-time":"2020-07-02T04:31:03Z","timestamp":1593664263000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Differences in gait analysis and clinical outcome after TightRope\u00ae or screw fixation in acute syndesmosis rupture: study protocol for a prospective randomized pilot study"],"prefix":"10.1186","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8563-3493","authenticated-orcid":false,"given":"Julian","family":"Doll","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stefan","family":"Waizenegger","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Bruckner","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gerhard","family":"Schmidmaier","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sebastian I.","family":"Wolf","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christian","family":"Fischer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2020,7,2]]},"reference":[{"issue":"2","key":"4550_CR1","doi-asserted-by":"publisher","first-page":"102","DOI":"10.1097\/00005131-200502000-00006","volume":"19","author":"B Weening","year":"2005","unstructured":"Weening B, Bhandari M. 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In the event that a patient\u2019s physical or mental health becomes jeopardized because of participation in the present study, the patient will be dismissed immediately and excluded from the study. All protocol modifications will be registered with the DRKS, published in the final paper and communicated to the participants. Before inclusion into the trial, participants will be informed both orally and in writing about all relevant aspects of the trial (e.g., aims, methods, anticipated benefits, potential risks of the study, and possibly entailed discomfort). Participants must be at least 18\u2009years of age and provide written informed consent. They have to be able to understand the character and individual consequences of the clinical trial. The participants\u2019 free decision to participate will be documented by signature on the informed consent form.All patient-related information is subject to medical confidentiality and to medical secrecy, the European General Data Protection Regulation (DSGVO\u2014Datenschutz-Grundverordnung), the Federal Data Protection Act (Bundesdatenschutzgesetz), and the State Data Protection Act (Landesdatenschutzgesetz). Third parties will not have any insight into original data.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable. This manuscript does not contain data from any individual person.","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":"606"}}