Use of in-house three-dimensional printed anatomical models in pre-operative planning to improve surgical outcomes in patients undergoing surgery for isolated orbital floor fractures: an open-label, randomized, clinical trial

Abstract

BACKGROUND: Orbital floor fractures are frequent among young adults, and their anatomy poses a challenge for any surgeon. Accurate reconstruction is imperative to restore normal anatomy and prevent potential sequelae such as persistent enophthalmos, which may lead to visual implications, including diplopia. An innovative approach to improve accurate reconstruction is based on the integration of in-house three-dimensional (3D) printing into pre-operative planning. This methodology involves the creation of individualized anatomical models based on patients' pre-operative CT scans, offering precise representations of unique fracture characteristics. OBJECTIVES: The main objective is to investigate the impact of using in-house 3D printed anatomical model for pre-operative planning in isolated orbital floor fractures on the occurrence of persistent enophthalmos, measured 1 month after surgery. Secondary objectives include assessing post-operative complications 1 month after surgery (persistent diplopia, infraorbital nerve dysfunction and restricted EOM motility) and evaluating patients’ understanding and satisfaction regarding the information received before the surgical procedure. DESIGN: This study is designed as a multicentric, prospective, open-label, randomized clinical trial carried out from November 2023 to March 2027. PARTICIPANTS AND METHODS: A total of 132 patients undergoing surgery for an isolated orbital floor fracture will be enrolled using a non-probabilistic consecutive sampling method. They will be randomly assigned to Group A (pre-operative planning using in-house 3D printed models) or Group B (conventional pre-operative planning). Data on study variables will be collected and analysed. By investigating the effectiveness of incorporating 3D printed anatomical models in pre-operative planning, this study seeks to contribute to the advancement of Oral and Maxillofacial (OMF) surgical practices, with potential implications for reducing complications and improving both functional and aesthetic outcomes