Abstract
BackgroundAn anatomical reconstruction of the ankle congruity is the important prerequisite in the operative treatment of acute ankle fractures. Despite anatomic restoration patients regularly suffer from residual symptoms after these fractures. There is growing evidence, that a poor outcome is related to the concomitant traumatic intra-articular pathology. By supplementary ankle arthroscopy anatomic reduction can be confirmed and associated intra-articular injuries can be treated. Nevertheless, the vast majority of complex ankle fractures are managed by open reduction and internal fixation (ORIF) only. Up to now, the effectiveness of arthroscopically assisted fracture treatment (AORIF) has not been conclusively determined. Therefore, a prospective randomised study is needed to sufficiently evaluate the effect of AORIF compared to ORIF in complex ankle fractures.Methods/designWe perform a randomised controlled trial at Munich University Clinic enrolling patients (18–65 years) with an acute ankle fracture (AO 44 A2, A3, B2, B3, C1 - C3 according to AO classification system). Patients meeting the inclusion criteria are randomised to either intervention group (AORIF, n = 37) or comparison group (ORIF, n = 37). Exclusion criteria are fractures classified as AO type 44 A1 or B1, pilon or plafond-variant injury or open fractures. Primary outcome is the AOFAS Score (American Orthopaedic Foot and Ankle Society). Secondary outcome parameter are JSSF Score (Japanese Society of Surgery of the Foot), Olerud and Molander Score, Karlsson Score, Tegner Activity Scale, SF-12, radiographic analysis, arthroscopic findings of intra-articular lesions, functional assessments, time to return to work/sports and complications. This study protocol is accordant to the SPIRIT 2013 recommendation. Statistical analysis will be performed using SPSS 22.0 (IBM).DiscussionThe subjective and functional outcome of complex ankle fractures is regularly unsatisfying. As these injuries are very common it is essential to improve the postoperative results. Potentially, arthroscopically assisted fracture treatment can significantly improve the outcome by addressing the intra-articular pathologies. Given the absolute lack of studies comparing AORIF to ORIF in complex ankle fractures, this randomised controlled trail is urgently needed to evaluate the effectiveness of additional arthroscopy.Trial registrationClinicalTrials.gov reference: NCT02449096 (Trial registration date: April 7th, 2015).
Highlights
An anatomical reconstruction of the ankle congruity is the important prerequisite in the operative treatment of acute ankle fractures
Arthroscopically assisted fracture treatment can significantly improve the outcome by addressing the intra-articular pathologies
Given the absolute lack of studies comparing arthroscopically assisted open reduction and internal fixation (AORIF) to open reduction and internal fixation (ORIF) in complex ankle fractures, this randomised controlled trail is urgently needed to evaluate the effectiveness of additional arthroscopy
Summary
An anatomical reconstruction of the ankle congruity is the important prerequisite in the operative treatment of acute ankle fractures. In case of acute fractures to the ankle, the sensitivity is further reduced due to the traumatic oedema leading to a misjudgement of the appearance and size of OCLs [14] In this context, many authors have emphasized the value of ankle arthroscopy [6, 7, 15]. Arthroscopically assisted open reduction and internal fixation (AORIF) allows a confirmation of the anatomic reduction, careful examination of the cartilage, capsular and intra-articular ligaments. There are only two randomised controlled trials evaluating the effect of additional ankle arthroscopy in isolated fractures of the distal fibula at the level of the syndesmosis (AO type 44 B1) Both documented a high incidence of intra-articular damage. We perform the first randomised controlled trial intended to report the short, midterm- and long-term follow-up of patients who underwent operative treatment of complex ankle fractures – with and without ankle arthroscopy
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