title: Medium-sized posterior fragments in AO Weber-B fractures, does open reduction and fixation improve outcome? the POSTFIX-trial protocol, a multicenter randomized clinical trial.
abstract: Guidelines for treatment of the posterior fracture fragment in trimalleolar fractures are scarce and show varying advices. Did the increasing size of the posterior fragment seem to relate to worse outcome in the past, nowadays this has changed to the amount of dislocation of the posterior fragment post-operatively. Despite many retrospective cohort studies and some prospective cohort studies, no consistent guideline could be derived from the current literature.
  
  
  
  The POSTFIX-study is designed as a multicenter randomized clinical trial to analyse the effects of anatomical reduction and fixation of the posterior fragment in AO 44-B3 fractures with medium-sized posterior fragment. A total of 84 patients will be included and online allocated to either anatomical reduction and fixation of the posterior fragment via the posterolateral approach (n = 42) or no fixation of the posterior fragment (n = 42). The concomitant fractured medial and lateral malleoli are treated according to the AO-principles. Functionality of the ankle as measured by the AAOS-questionnaire (American Association of Orthopaedic Surgeons) 1 year post-operatively was set as primary outcome. Main secondary outcome measures are the AAOS-questionnaire 5 years postoperatively and osteoarthritis as measured on plain radiographs 1 year and 5 years post-operatively. The Olerud and Molander score, the AOFAS-score, the VAS-pain, the Euroqol-5D and Range of Motion by physical examination will also be evaluated during the follow-up period.
  
  
  
  The POSTFIX-trial is the first high quality multicenter randomized clinical trial worldwide to analyse the effects of anatomical fixation of the posterior fragment in trimalleolar fractures. New guidelines on anatomical reduction and fixation of the posterior fragment can in future be based on the results of this trial.
  
  
  
  This trial is registered on ClinicalTrials.gov with reference number: NCT02596529 . Registered 3 November 2015, retrospectively registered.
authors.affiliation: Trauma-unit Haaglanden MC, The Hague, The Netherlands. sanverhage@hotmail.com.
authors.forename: Sander
authors.identifier: 0000-0002-4873-4682
authors.initials: S
authors.lastname: Verhage
authors.affiliation: Trauma-unit Haaglanden MC, The Hague, The Netherlands.
authors.forename: Peer
authors.initials: P
authors.lastname: van der Zwaal
authors.affiliation: Trauma-unit Haaglanden MC, The Hague, The Netherlands.
authors.forename: Maarten
authors.initials: M
authors.lastname: Bronkhorst
authors.affiliation: Department of Traumasurgery, Haga Ziekenhuis, The Hague, The Netherlands.
authors.forename: Huub
authors.initials: H
authors.lastname: van der Meulen
authors.affiliation: Department of Traumasurgery, Haga Ziekenhuis, The Hague, The Netherlands.
authors.forename: Sanne
authors.initials: S
authors.lastname: Kleinveld
authors.affiliation: Trauma-unit Haaglanden MC, The Hague, The Netherlands.
authors.forename: Sven
authors.initials: S
authors.lastname: Meylaerts
authors.affiliation: Trauma-unit Haaglanden MC, The Hague, The Netherlands.
authors.forename: Steven
authors.initials: S
authors.lastname: Rhemrev
authors.affiliation: Department of Traumasurgery, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: Pieta
authors.initials: P
authors.lastname: Krijnen
authors.affiliation: Department of Traumasurgery, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: Inger
authors.initials: I
authors.lastname: Schipper
authors.affiliation: Trauma-unit Haaglanden MC, The Hague, The Netherlands.
authors.forename: Jochem
authors.initials: J
authors.lastname: Hoogendoorn
mesh_terms: D064386:Ankle Fractures / Q000000981:diagnostic imaging* / Q000453:epidemiology / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D005593:Fracture Fixation, Internal / Q000379:methods* / Q000592:standards; D006801:Humans; D008297:Male; D009426:Netherlands / Q000453:epidemiology; D016896:Treatment Outcome
keywords: Ankle fracture; Posterior fragment fixation; Posterior malleolar fracture; Posterolateral approach; Trimalleolar fracture