Junyu Li1, Lin Huang2, Wenyu Zhou3, Zizhen Wang4, Zongze Li5, Lin Zeng1, Zhongjun Liu1, Huiyong Shen2, Zhaopeng Cai2, Hongsheng Gu3, Xinjian Yang3, Rui Zhang3, Wanheng Hu6, Miao Yu1, Jianting Chen5. 1. Department of Orthopedics, Peking University Third Hospital, Beijing, China. 2. Department of Orthopedics, Sun Yat-sen Memorial Hospital, Guangzhou, China. 3. Department of Orthopedics, Shenzhen Second People's Hospital, Shenzhen, China. 4. Peking University Health Science Center, Beijing, China. 5. Department of Orthopedics, Southern Medical University Nanfang Hospital, Guangzhou, China. 6. Department of Science and Technology Studies, Cornell University, Ithaca, New York, USA.
Abstract
BACKGROUND: To introduce a novel robotic system 'Orthbot' that has been developed and tested as a surgical assistant for auto-placement of the K-wire in lumbar fusion. METHODS: This is a multi-centre, randomized controlled clinical study that includes 56 patients (robot group, RG: 27, free-hand group, FG: 29). Following the pre-operative planning and intra-operative fluoroscopic images, the 'Orthbot' automatically completed registration and K-wire placement under the supervision of the surgeon. Deviation distance (DD) and deviation angle (DA) were used as the primary parameters to evaluate the accuracy of the robotic system. RESULTS: The average DD was 0.95 ± 0.377 mm and 4.35 ± 2.01 mm, respectively in the RG and FG (p < 0.001). The average DA of the K-wire in the coronal plane and the sagittal plane in X-Ray was respectively 6.80 ± 7.79° and 1.27 ± 2.32° in the RG (p < 0.001), and 22.22 ± 16.85° and 4.57 ± 3.86° in the FG (p < 0.001), which showed a higher accuracy rate in the robotic-assisted cases compared to the free-hand cases. CONCLUSIONS: The novel robotic system could achieve accurate K-wire insertions as indicated by the radiological results.
RCT Entities:
BACKGROUND: To introduce a novel robotic system 'Orthbot' that has been developed and tested as a surgical assistant for auto-placement of the K-wire in lumbar fusion. METHODS: This is a multi-centre, randomized controlled clinical study that includes 56 patients (robot group, RG: 27, free-hand group, FG: 29). Following the pre-operative planning and intra-operative fluoroscopic images, the 'Orthbot' automatically completed registration and K-wire placement under the supervision of the surgeon. Deviation distance (DD) and deviation angle (DA) were used as the primary parameters to evaluate the accuracy of the robotic system. RESULTS: The average DD was 0.95 ± 0.377 mm and 4.35 ± 2.01 mm, respectively in the RG and FG (p < 0.001). The average DA of the K-wire in the coronal plane and the sagittal plane in X-Ray was respectively 6.80 ± 7.79° and 1.27 ± 2.32° in the RG (p < 0.001), and 22.22 ± 16.85° and 4.57 ± 3.86° in the FG (p < 0.001), which showed a higher accuracy rate in the robotic-assisted cases compared to the free-hand cases. CONCLUSIONS: The novel robotic system could achieve accurate K-wire insertions as indicated by the radiological results.