About this trial
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.
Eligibility criteria
Qualifiers
Unilateral, acute, closed distal tibial fractures (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association AO/OTA 43-A)
Time from injury to surgery < 21 days
Able to walk independently before injury (assistive devices allowed)
Disqualifiers
Open fractures or multiple severe traumas requiring priority treatment
Asymmetrical lower extremities, or prior malunion of the ipsilateral tibia, or pre-existing deformities significantly affecting rotation/length evaluation
Ipsilateral fractures combined with other sites
Pathological fractures (tumor/metabolic)
Trial design
Treatments tested in this trial
- Robot-assisted closed reduction
- Traditional surgeon-led reduction
Treatment groups
Sponsors and collaborators
Beijing Jishuitan Hospital
Lead sponsor
Aerospace Center Hospital
Collaborator