Operative versus non-operative treatment for non-displaced Lisfranc injuries: A two-center randomized clinical trial

Abstract

Background and aims: There is no consensus on which Lisfranc injuries can be treated non-operatively. The aim of the study was to compare non-operative treatment and open reduction and internal fixation (ORIF) in the treatment of non-displaced Lisfranc injuries. Materials and methods: This study was a multicenter randomized controlled trial (RCT) conducted at two hospitals in Finland between 19 March 2012, and 20 December 2022, with a target sample size of 60 patients. The primary outcome was Visual Analogue Scale Foot and Ankle (VAS-FA) at 2 years. The secondary outcomes included VAS-FA pain, function, and other complaints subscales and the American Orthopedic Foot & Ankle Society (AOFAS) Midfoot Scale. All outcomes were measured at 6 months, 1 and 2 years. Results: Altogether 27 patients with computed tomography (CT)-confirmed non-displaced Lisfranc injuries were enrolled in this trial resulting in an underpowered trial. In patients with non-displaced Lisfranc injuries, the mean VAS-FA overall score in the non-operative group was 96.1 [confidence interval (CI): 91.5–100] and 91.8 [86.9–96.7] in the ORIF group at 2 years with no statistically significant difference between the groups (mean between-group difference (MD) 4.3 [CI, −2.4 to 11], Cohen’s d = 0.706) in this underpowered RCT. Conclusion: There was no difference in VAS-FA between non-operative and ORIF in patients with non-displaced Lisfranc injuries, but the trial is underpowered to draw robust conclusions.