Xi Gong1, Yang He2, Jingang An3, Yao Yang4, Xiuling Huang4, Meng Liu4, Yangyang Zhao4, Yi Zhang5. 1. Resident, Department of Oral and Maxillofacial Surgery (formerly); Second Dental Center (currently), Peking University School and Hospital of Stomatology, Beijing, China. 2. Attending Doctor, Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology, Beijing, China. 3. Associate Professor, Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology, Beijing, China. 4. Resident, Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology, Beijing, China. 5. Professor and Department Head, Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology, Beijing, China. Electronic address: zhangyi2000@263.net.
Abstract
PURPOSE: The delayed treatment of zygomatic complex (ZMC) fracture presents a difficult challenge to surgeons. The aim of this study was to compare the treatment effects of delayed surgery of ZMC fractures with and without a computer-assisted navigation system (CANS). MATERIALS AND METHODS: In this observer-blinded single-site randomized clinical trial, patients with unilateral ZMC fracture were included and randomized 1:1 to delayed treatment with or without CANS. The primary outcome measurement was the absolute bilateral differences of the ZMC eminence and width based on computed tomographic (CT) measurements 48 to 72 hours after surgery. RESULTS:One hundred three patients with unilateral ZMC fracture without immediate treatment were enrolled, and 78 were randomized to each group. Postoperative CT measurements showed that the bilateral difference in ZMC eminence was significantly less for the navigation group than for the control group (1.24 vs 2.22 mm; P < .001). The bilateral difference in ZMC width was not significantly different between the 2 groups (0.94 vs 1.36 mm; P = .061). The percentage of patients exhibiting a morphologically symmetrical face (bilateral differences ≤2 mm in ZMC eminence and width) was 71.8% (28 of 39) for the navigation group and 35.9% (14 of 39) for the control group (P = .001). Photogrammetry showed that the average difference between the postoperative CT data and the preoperative design was smaller in the navigation group (1.30 vs 2.40 mm; P = .012). CONCLUSIONS: Use of CANS improved ZMC symmetry in patients with unilateral ZMC fracture who had delayed treatment by allowing for more accurate implementation of the preoperative plan.
RCT Entities:
PURPOSE: The delayed treatment of zygomatic complex (ZMC) fracture presents a difficult challenge to surgeons. The aim of this study was to compare the treatment effects of delayed surgery of ZMCfractures with and without a computer-assisted navigation system (CANS). MATERIALS AND METHODS: In this observer-blinded single-site randomized clinical trial, patients with unilateral ZMCfracture were included and randomized 1:1 to delayed treatment with or without CANS. The primary outcome measurement was the absolute bilateral differences of the ZMC eminence and width based on computed tomographic (CT) measurements 48 to 72 hours after surgery. RESULTS: One hundred three patients with unilateral ZMCfracture without immediate treatment were enrolled, and 78 were randomized to each group. Postoperative CT measurements showed that the bilateral difference in ZMC eminence was significantly less for the navigation group than for the control group (1.24 vs 2.22 mm; P < .001). The bilateral difference in ZMC width was not significantly different between the 2 groups (0.94 vs 1.36 mm; P = .061). The percentage of patients exhibiting a morphologically symmetrical face (bilateral differences ≤2 mm in ZMC eminence and width) was 71.8% (28 of 39) for the navigation group and 35.9% (14 of 39) for the control group (P = .001). Photogrammetry showed that the average difference between the postoperative CT data and the preoperative design was smaller in the navigation group (1.30 vs 2.40 mm; P = .012). CONCLUSIONS: Use of CANS improved ZMC symmetry in patients with unilateral ZMCfracture who had delayed treatment by allowing for more accurate implementation of the preoperative plan.