Clinical Research Directory

Robot-Assisted Closed Reduction and Internal Fixation for Intertrochanteric Femoral Fractures

The goal of this clinical trial is to compare the clinical effectiveness and safety of robot-assisted autonomous closed reduction versus traditional manual closed reduction in adult patients aged 18 to 80 years with acute, closed intertrochanteric femoral fractures (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association \[AO/OTA\] classification 31-A). The main question it aims to answer is: Whether robot-assisted autonomous closed reduction can achieve a significantly higher rate of excellent and good bone fracture reduction compared to traditional manual reduction, as rigorously evaluated by low-dose computed tomography (CT) and a three-dimensional (3D) quantitative standard. Researchers will compare the robot-assisted autonomous closed reduction group (intervention group) to the traditional manual closed reduction group (control group) to see if the robotic system significantly improves 3D anatomical reduction precision, reduces intraoperative fluoroscopy times and radiation doses, shortens operation times, and ultimately enhances long-term clinical hip functions and health-related quality of life. Participants will be asked to do the following tasks: Complete baseline medical screening, standard hip X-rays, and bilateral full-length thin-layer CT scans before the surgery. Undergo a 1:1 randomized allocation after anesthesia to receive either robot-assisted autonomous closed reduction or traditional experience-based manual closed reduction, both followed by conventional proximal femoral intramedullary nailing internal fixation. Receive post-operative low-dose CT scans before discharge or within 2 weeks after surgery to evaluate the fracture reduction quality. Follow a standardized Enhanced Recovery After Surgery (ERAS) rehabilitation pathway and attend scheduled follow-up visits at 1, 3, and 6 months after the surgery to monitor bone healing, hip functions, and quality of life