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Robot-Assisted Closed Reduction and Internal Fixation for Extra-Articular Distal Tibial Fractures
Sponsor: Beijing Jishuitan Hospital
Summary
This study aims to evaluate the clinical efficacy and safety of an intelligent fracture reduction robot system in treating extra-articular distal tibial fractures. Traditional manual bone setting depends heavily on a surgeon's experience, which can sometimes lead to inconsistent alignment and increased radiation exposure. This clinical trial compares robot-assisted closed reduction against the traditional surgeon-led method. The primary goal is to determine if the robotic system improves the rate of accurate fracture alignment (excellent and good reduction rate) and helps patients recover better.
Official title: Key Technology Research and Development for Intelligent Minimally Invasive Precision Treatment of Fractures (Sub-project 4: A Randomized Controlled Trial of Robot-Assisted Closed Reduction and Internal Fixation for Distal Tibial Fractures)
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-07-01
Completion Date
2028-12-31
Last Updated
2026-07-29
Healthy Volunteers
No
Conditions
Interventions
Robot-assisted closed reduction
The patient undergoes automated or human-robot collaborative closed fracture reduction powered by an intelligent robotic system. The system integrates deep-learning-based bone segmentation, automatic reduction planning, and a self-adaptive 2D-3D image registration framework to achieve sub-millimeter positioning feedback and force-position collaborative security gates. Following successful reduction, the fracture is fixed with a distal tibial locking plate via the minimally invasive percutaneous plate osteosynthesis (MIPO) technique.
Traditional surgeon-led reduction
The patient undergoes conventional closed or open fracture reduction performed entirely by the surgical team based on traditional clinical experience under ordinary C-arm fluoroscopic guidance. Internal fixation is achieved using standard distal tibial locking plates or intramedullary nails according to the surgeon's choice and standard of care.
Locations (2)
Aerospace Center Hospital
Beijing, Beijing Municipality, China
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, China