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

RecruitingNAAges 18 Years - 80 YearsAllBeijing Jishuitan Hospital
NCT07738406 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 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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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) Exclusion Criteria: * 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) * 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 * Deemed unsuitable by the investigator (e.g., unable to follow up, or extreme obesity severely limiting the surgical or robotic workspace) * Refused randomization or enrollment
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What it tests

  • Robot-assisted closed reduction
  • Conventional fracture reduction and internal fixation
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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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