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

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Beijing Jishuitan Hospital

Lead sponsor

Aerospace Center Hospital

Collaborator