Ligamentous Lisfranc injuries: a pilot multicentre randomised controlled trial examining primary arthrodesis versus fixation as best surgical treatment

The mini-MALLET pilot trial is a feasibility, multi-centre, randomised controlled trial examining the functional, radiographic, and surgical outcomes of fusion versus (bridge plate) fixation of the ligamentous Lisfranc injury. Current practice is to identify patients with a ligamentous Lisfranc injury through plain x-ray films as well as computerised tomography (CT) scans on review in emergency. This service is delivered as part of the Christchurch Hospital practice. Once identified as having a ligamentous Lisfranc injury, they would be offered operative treatment (as is considered the literature-backed norm) though the modality of this treatment (fixation versus fusion) is at the discretion of the operating surgeon. There is equipoise here, as neither option has been convincingly proven as superior to the other thus far in the known literature. Under the pilot mini-MALLET trial, this same cohort of patients will be offered entry into the trial, wherein they would still receive treatment through the same service (the orthopaedic department of Christchurch Hospital) with study oversight from the trial investigators. Their treatment would still be delivered through the hospital acutely (Christchurch Health Campus) and through the clinic (again at the Health Campus with occasional review in the Burwood clinic rooms, under the same District Health Board banner). They will be followed out to one year post their intervention. Once entered into the trial, participants would be randomised to either fixation or fusion treatment. Those in the fixation arm will receive an open surgical approach when the participant is surgically prepared (swelling appropriate, consented appropriately, and surgical time allowed) to the Lisfranc complex of the foot under general anaesthetic, reduction and then fixation of the joint(s) involved using plate and screws, and closure of the wound through surgeon’s preference. They would then be discharged from hospital once cleared by the multi-disciplinary team of allied and medical health workers as safe for discharge, as is currently routine, to be followed up in clinic over the course of the next year.