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

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.

NCT Number	NCT07733271
Lead Sponsor	Beijing Jishuitan Hospital Collaborators: Aerospace Center Hospital
Conditions	Distal Tibial Fracture, Tibial Fractures
Enrollment	60 participants
Start Date	2026-07-01
Primary Completion	2027-12-31 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-29