Evaluating Robot-Assisted Versus Traditional Surgery for Treating Distal Tibial Fractures with an Intelligent Fracture Reduction Robot System

What this Trial Is About

This research evaluates the use of an intelligent fracture reduction robot system compared to traditional surgeon-led methods for treating extra-articular distal tibial fractures. The study focuses on whether the robotic system can improve the accuracy of fracture alignment and enhance patient recovery, addressing challenges in manual bone setting such as variability in surgeon experience and radiation exposure. Participants will receive either robot-assisted closed fracture reduction using a system with advanced imaging and positioning technology combined with minimally invasive internal fixation, or traditional closed or open reduction performed by surgeons using standard fluoroscopic guidance and fixation methods. The study uses a randomized, parallel design with two groups one receiving the robot-assisted procedure and the other the traditional surgical approach. During the study, participants will undergo assessments including postoperative low-dose CT scans to evaluate fracture reduction quality, measurements of operation time, fluoroscopy exposure, blood loss, hospital stay length, and functional recovery scores up to 12 months after surgery. Safety monitoring includes tracking intraoperative and postoperative complications and any reoperations. The total follow-up for each participant extends to one year after surgery to assess fracture healing and functional outcomes.

Robot-Assisted Closed Reduction and Internal Fixation for Extra-Articular Distal Tibial Fractures