About this trial
This study aims to evaluate the clinical efficacy and safety of an intelligent robotic system for the closed reduction of extra-articular supracondylar femoral fractures (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association AO/OTA 33-A). Traditional manual reduction for supracondylar femoral fractures is often challenging due to strong muscle pull, heavily relying on the surgeon's experience and frequently requiring repeated fluoroscopy. This clinical trial compares robot-assisted closed reduction against traditional surgeon-led reduction methods. The primary goal is to determine if the robotic system improves the precision of bone alignment (excellent and good reduction rate) and functional recovery while reducing surgical radiation exposure.
Eligibility criteria
Qualifiers
Age between 18 and 80 years old
Unilateral, acute, closed extra-articular supracondylar femoral fracture (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association AO/OTA 33-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 femur, or pre-existing deformities significantly affecting rotation/length evaluation
Unilateral fractures combined with other sites
Pathological fractures (tumor or metabolic)
Trial design
Treatments tested in this trial
- Robot-assisted closed reduction
- Conventional fracture reduction and internal fixation
Treatment groups
Sponsors and collaborators
Beijing Jishuitan Hospital
Lead sponsor
Aerospace Center Hospital
Collaborator