Chaoying Han1, Dilnur Dilxat1, Xiao Zhang1, Hui Li1, Jinlong Chen2, Lei Liu3. 1. Resident, State Key Laboratory of Oral Diseases; National Clinical Research Center for Oral Diseases; Department of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, Chengdu, China. 2. Attending Staff, State Key Laboratory of Oral Diseases; National Clinical Research Center for Oral Diseases; Department of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, Chengdu, China. 3. Professor, State Key Laboratory of Oral Diseases; National Clinical Research Center for Oral Diseases; Department of Oral and Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University, Chengdu, China. Electronic address: drliulei@163.com.
Abstract
PURPOSE: Accurate reduction of intracapsular condylar fractures is the key to successful reconstruction of the temporomandibular joint and remains a challenge for oral and maxillofacial surgeons. The aim of the study was to evaluate quantitatively the effect of surgical navigation on the accuracy of reduction of intracapsular fractures. MATERIALS AND METHODS: In this prospective randomized nonblinded controlled clinical trial, patients diagnosed with intracapsular condylar fractures who were scheduled for surgical treatment were included and randomized to open treatment with or without surgical navigation. The primary predictor variable was surgical navigation. The primary outcome variable was the average distance (AD) between preoperative and postoperative computed tomographic measurements. The second outcome variable was the rate of anatomic reduction. The χ2 test and independent-samples t test were used for statistical analyses. RESULTS:Twenty patients (33 sides) with intracapsular condylar fractures were enrolled and treated with open surgery (13 male, 7 female; mean age, 28.65 yr; range, 13 to 54 yr). Of these, 10 patients (16 sides) and 10 patients (17 sides) were treated, respectively, with and without surgical navigation technology. All patients underwent follow-up at 1, 3, 6, and 12 months. The mean AD was 0.5235 mm in the navigation group and 1.170 mm in the control group (P < .001). The rate of anatomic reduction was 93.8% in the navigation group and 88.2% in the control group (P = .58). The results indicated that a more precise reduction was achieved in the navigation group than in the control group. CONCLUSION: According to the study results, the rate of anatomic reduction increased and the ADs decreased in the navigation group compared with the control group. Therefore, surgical navigation could increase the accuracy of reduction during the surgical treatment of intracapsular condylar fractures.
RCT Entities:
PURPOSE: Accurate reduction of intracapsular condylar fractures is the key to successful reconstruction of the temporomandibular joint and remains a challenge for oral and maxillofacial surgeons. The aim of the study was to evaluate quantitatively the effect of surgical navigation on the accuracy of reduction of intracapsular fractures. MATERIALS AND METHODS: In this prospective randomized nonblinded controlled clinical trial, patients diagnosed with intracapsular condylar fractures who were scheduled for surgical treatment were included and randomized to open treatment with or without surgical navigation. The primary predictor variable was surgical navigation. The primary outcome variable was the average distance (AD) between preoperative and postoperative computed tomographic measurements. The second outcome variable was the rate of anatomic reduction. The χ2 test and independent-samples t test were used for statistical analyses. RESULTS: Twenty patients (33 sides) with intracapsular condylar fractures were enrolled and treated with open surgery (13 male, 7 female; mean age, 28.65 yr; range, 13 to 54 yr). Of these, 10 patients (16 sides) and 10 patients (17 sides) were treated, respectively, with and without surgical navigation technology. All patients underwent follow-up at 1, 3, 6, and 12 months. The mean AD was 0.5235 mm in the navigation group and 1.170 mm in the control group (P < .001). The rate of anatomic reduction was 93.8% in the navigation group and 88.2% in the control group (P = .58). The results indicated that a more precise reduction was achieved in the navigation group than in the control group. CONCLUSION: According to the study results, the rate of anatomic reduction increased and the ADs decreased in the navigation group compared with the control group. Therefore, surgical navigation could increase the accuracy of reduction during the surgical treatment of intracapsular condylar fractures.