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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Jishuitan Hospital

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

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Beijing Jishuitan Hospital

Lead sponsor

Aerospace Center Hospital

Collaborator