A study protocol for a randomised controlled trial evaluating the effects of intraoperative computed tomography on the outcomes of zygomatic fractures

BACKGROUND: Zygomaticomaxillary complex (ZMC) and zygomatic arch (ZA) fractures are common injuries resulting from facial trauma and frequently require surgical management (Huang et al., Craniomaxillofac Trauma Reconstr 8(4):271-6, 2015). A substantial number of post-operative functional and cosmetic complications can arise from the surgical management of these fractures. These include scarring, inadequate facial profile restoration, facial asymmetries and diplopia (Ellis et al. J Oral Maxillofac Surg 54(4):386-400, 1996; Yang et al. Oral Maxillofac Surg Clin North Am 23(1):31-45, 2011; Kloss et al. Int J Oral Maxillofac Surg 40(1):33-7, 2011). Intuitively, most of these aforementioned complications arise as a result of inadequate fracture reduction; however, current standard practice is to assess reduction post-operatively through plain radiographs or computed tomography (CT) scans. The role of intra-operative CT scanning to assess the reduction of ZMC/ZA fractures and the potential impact on complications, has thus far not been established. METHODS: This is a prospective randomised controlled trial currently being undertaken at the Royal Brisbane and Women’s Hospital. All patients who require operative management of their ZMC or ZA fractures are offered enrollment in the trial. The patients are randomised into two groups: interventional (intra-operative CT) and control (no intra-operative CT). All patients in each group will have post-operative radiographs taken. From these radiographs, the reduction of the ZMC and/or ZA fracture is graded by a blinded assessor. Patients will be reviewed in clinic at 1 week and 6 weeks post-surgery. During these consultations, all patients will be assessed for scarring, diplopia, facial profile restoration and need for revision surgery. DISCUSSION: Many complications associated with surgical management of ZMC and ZA fractures involve poor aesthetic results as a direct consequence of inadequate fracture reduction. Inadequate fracture reduction is predictable given that small incisions are used and only limited visualisation of the fractures is possible during the procedure. This is due to a desire to limit scarring and reduce the risk of damage to vital structures in an aesthetically sensitive region of the body. It follows that an intraoperative adjunctive tool such as a CT scan, which can assist in visualisation of the fractures and the subsequent reduction, could potentially improve reduction and reduce complications. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12616000693426. Registered on 26 May 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3625-8) contains supplementary material, which is available to authorized users.