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

BMC Musculoskeletal Disorders

Study Protocol

Sanne Kleinveld¹  Huub van der Meulen¹  Inger Schipper²  Pieta Krijnen²  Jochem Hoogendoorn³  Sven Meylaerts³  Maarten Bronkhorst³  Steven Rhemrev³  Sander Verhage³  Peer van der Zwaal³ 

[1] Department of Traumasurgery, Haga Ziekenhuis, The Hague, The Netherlands;Department of Traumasurgery, Leiden University Medical Center, Leiden, The Netherlands;Trauma-unit Haaglanden MC, The Hague, The Netherlands;

关键词: Trimalleolar fracture;    Posterior malleolar fracture;    Posterior fragment fixation;    Ankle fracture;    Posterolateral approach;   

DOI  :  10.1186/s12891-017-1445-0

 received in 2016-07-13, accepted in 2017-02-07,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundGuidelines 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.MethodsThe 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.DiscussionThe 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.Trial registrationThis trial is registered on ClinicalTrials.gov with reference number: NCT02596529. Registered 3 November 2015, retrospectively registered.

【 授权许可】

CC BY   
© The Author(s). 2017