{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,20]],"date-time":"2026-07-20T10:15:35Z","timestamp":1784542535406,"version":"3.55.0"},"reference-count":42,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2021,12,7]],"date-time":"2021-12-07T00:00:00Z","timestamp":1638835200000},"content-version":"unspecified","delay-in-days":6,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100018949","name":"Oulun Yliopistollinen Sairaala","doi-asserted-by":"publisher","award":["9R006"],"award-info":[{"award-number":["9R006"]}],"id":[{"id":"10.13039\/501100018949","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Surg Interv Health Technologies"],"accepted":{"date-parts":[[2021,11,1]]},"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:p>Roughly two-thirds of ankle fractures are unimalleolar injuries, the Weber B-type fibula fracture being by far the most common type. Depending on the trauma and the accompanying soft-tissue injury, these fractures are either stable or unstable. Current clinical practice guidelines recommend surgical treatment for unstable Weber B-type fibula fractures. An ongoing randomized, parallel group, non-inferiority trial comparing surgery and non-operative treatment for unstable Weber B-type ankle fractures with allocation ratio 1:1. The rationale for non-inferiority design is as follows: By being able to prove non-inferiority of non-operative treatment, we would be able to avoid complications related to surgery. However, the primary concern related to non-operative treatment is increased risks of ankle mortise incongruency, leading to secondary surgery, early post-traumatic osteoarthritis and poor function. After providing informed consent, 126 patients aged 16 years or older with an unimalleolar Weber B-type unstable fibula fracture were randomly assigned to surgery (open reduction and internal fixation) or non-operative treatment (6-week cast immobilization). We have completed the patient enrolment and are currently in the final stages of the 2-year follow-up. The primary, non-inferiority outcome is the Olerud-Molander Ankle Score (OMAS) at 2 years (primary time point). The predefined non-inferiority margin is set at 8 OMAS points. Secondary outcomes include the Foot and Ankle Score, a 100 mm Visual Analogue Scale for function and pain, the RAND-36-Item Health Survey for health-related quality-of-life, the range-of-motion of the injured ankle, malunion (ankle joint incongruity) and fracture union. Treatment-related complications and harms; symptomatic non-unions, loss of congruity of the ankle joint, reoperations and wound infections will also be recorded. We hypothesize that non-operative treatment yields non-inferior functional outcome to surgery, the current standard treatment, with no increased risk of harms.<\/jats:p>","DOI":"10.1136\/bmjsit-2021-000098","type":"journal-article","created":{"date-parts":[[2021,12,8]],"date-time":"2021-12-08T16:55:21Z","timestamp":1638982521000},"page":"e000098","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":4,"title":["Surgery versus non-operative treatment for ER-stress unstable Weber-B unimalleolar fractures: a study protocol for a prospective randomized non-inferiority (Super-Fin) trial"],"prefix":"10.1136","volume":"3","author":[{"given":"Tero","family":"Kortekangas","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1546-6711","authenticated-orcid":false,"given":"Ristomatti","family":"Lehtola","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hannu-Ville","family":"Leskel\u00e4","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simo","family":"Taimela","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pasi","family":"Ohtonen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olli","family":"Savola","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teppo","family":"J\u00e4rvinen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harri","family":"Pakarinen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2021,12,8]]},"reference":[{"key":"2024101903151211000_3.1.e000098.1","doi-asserted-by":"publisher","DOI":"10.3109\/17453679809002355"},{"key":"2024101903151211000_3.1.e000098.2","doi-asserted-by":"publisher","DOI":"10.3113\/FAI.2011.0141"},{"key":"2024101903151211000_3.1.e000098.3","unstructured":"Weber BG . 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