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

RecruitingNAAges 18 Years - 80 YearsAllBeijing Jishuitan Hospital
NCT07733271 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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) Exclusion Criteria: * 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) * Prior complex implants in place or previous surgeries significantly affecting evaluation * Active infection or severe systemic medical contraindications (unable to tolerate anesthesia/surgery) * Cognitive impairment, poor compliance, pregnancy, or lactation * Poor local skin conditions (e.g., obvious blisters, severe soft tissue injury) * Deemed unsuitable by the investigator (e.g., unable to follow up as planned) or refused randomization/enrollment
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What it tests

  • Robot-assisted closed reduction
  • Traditional surgeon-led reduction
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Where

2 sites
Aerospace Center Hospital
Beijing, China
Beijing Jishuitan Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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