智能化骨折微创复位手术机器人系统治疗不稳定型骨盆骨折的随机对照研究

Objective To compare the short-term efficacy between our self-designed intelligent robot-assisted minimally invasive reduction system and conventional freehand reduction assisted by fluoroscopy in the treatment of unstable pelvic fractures by robot or fluoroscopy-assisted internal fixation with percutaneous screws. Methods A prospective randomized controlled trial was conducted to include eligible 35 patients with unstable pelvic fracture who were admitted to Department of Orthopaedic Trauma, Beijing Jishuitan Hospital from December 2021 to October 2022. They were randomized into 2 groups. The observation group[17 cases, 10 males and 7 females with an age of (44.0±17.4) years] was treated with robot-assisted minimally invasive reduction, followed by robot-assisted or fluoroscopic internal fixation with percutaneous screws; the control group[18 cases, 12 males and 6 females with an age of (38.8±15.0) years] was treated with freehand reduction assisted by fluoroscopy, followed by robot-assisted or fluoroscopic internal fixation with percutaneous screws. The 2 groups were compared in terms of operation time, intraoperative bleeding, successful reduction, reduction quality, incidence of surgical complications and postoperative functional scores. Results The 2 groups were comparable because there were no significant differences in the preoperative general data between them (P>0.05). The intraoperative fluoroscopy frequency[(32.4±17.5) times] and fluoroscopy time [(19.8±10.4) s] in the observation group were significantly lower or shorter than those in the control group [(60.8±26.6) times and (38.2±16.1) s], and the rate of successful reduction in the observation group was 100.0% (17/17), significantly higher than that in the control group[72.2% (13/18)] (P<0.05). There was no significant difference between the 2 groups in intraoperative bleeding, operation time, reduction error, excellent and good rate of reduction after operation by Matta scoring, or Majeed functional score at 12 weeks after operation (P>0.05). Conclusion In the treatment of unstable pelvic fractures, since our self-designed intelligent robot-assisted minimally invasive reduction system can plan autonomously the reduction paths and accomplish minimally invasive reduction of the fracture with 3D images real-time monitoring, it is advantageous over conventional reduction methods in a higher success rate and less radiation exposure.