Open Reduction Internal Fixation vs Primary Arthrodesis for Displaced Lisfranc Injuries: A Multicenter Randomized Controlled Trial.

BACKGROUND:There is no consensus whether the primary surgical method should be open reduction and internal fixation (ORIF) or primary arthrodesis (PA) for Lisfranc injuries. The aim of our randomized controlled trial was to compare ORIF and PA for displaced Lisfranc injuries. METHODS:This study was a national multicenter randomized controlled trial. Altogether 43 displaced Lisfranc injuries were enrolled in this trial. The primary outcome measure was Visual Analogue Scale Foot and Ankle (VAS-FA) at a 24-months follow-up. The secondary outcome measures were VAS-FA pain, function, and other complaints subscales and the American Orthopaedic Foot & Ankle Society (AOFAS) Midfoot Scale. All outcomes were measured at 6, 12, and 24 months. We were unable to reach the planned sample size of 60 patients; thus, the study remains underpowered. RESULTS:The mean VAS-FA Overall score in the ORIF group was 86.5 (95% CI 77.9, 95.1) and 80.1 (95% CI 72.0, 88.1) in the PA group at the 24-month follow-up. We did not find eligible evidence of a difference in VAS-FA Overall scores (mean between-group difference 6.5 [95% CI -5.3, 18.2], Cohen d = 0.100). CONCLUSION:We did not find evidence of a difference in VAS-FA between ORIF and PA in patients with displaced Lisfranc injuries, and thus both are viable options for the initial surgical method. The trial is underpowered; however, the data may be included in a meta-analysis of similarly designed randomized controlled trials. TRIALS REGISTRATION:ClinicalTrials.gov identifier: NCT02953067 24 October 2016. LEVEL OF EVIDENCE:Level I, randomized controlled trial.