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

RecruitingNAAges 18 Years - 80 YearsAllBeijing Jishuitan Hospital
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to compare the clinical effectiveness and safety of robot-assisted autonomous closed reduction versus traditional manual closed reduction in adult patients aged 18 to 80 years with acute, closed intertrochanteric femoral fractures (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association \[AO/OTA\] classification 31-A). The main question it aims to answer is: Whether robot-assisted autonomous closed reduction can achieve a significantly higher rate of excellent and good bone fracture reduction compared to traditional manual reduction, as rigorously evaluated by low-dose computed tomography (CT) and a three-dimensional (3D) quantitative standard. Researchers will compare the robot-assisted autonomous closed reduction group (intervention group) to the traditional manual closed reduction group (control group) to see if the robotic syste

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 18 to 80 years, inclusive. * Male or female participants. * Acute, closed intertrochanteric femoral fracture. * AO/OTA classification 31-A intertrochanteric femoral fracture. * Fracture requiring closed reduction and proximal femoral intramedullary nailing. * Injury-to-surgery interval no more than 14 days. * Participant or legally authorized representative is fully informed about the study. * Written informed consent voluntarily provided by the participant or legally authorized representative. Exclusion Criteria: * Open fracture. * Pathological fracture. * Old fracture with an injury-to-surgery interval greater than 14 days. * Multiple fractures. * Previous surgery involving the affected hip joint. * Deformity of the affected hip joint. * Severe osteoarthritis of the affected hip joint. * Significant neuromuscular disease affecting lower limb function. * Significant neuromuscular disease affecting postoperative rehabilitation. * Severe systemic comorbidity that makes the participant unable to tolerate anesthesia or surgery. * Severe organ dysfunction that makes the participant unable to tolerate anesthesia or surgery. * Pregnancy. * Lactation. * Cognitive impairment that prevents compliance with postoperative follow-up or rehabilitation protocols. * Active psychiatric illness that prevents compliance with postoperative follow-up or rehabilitation protocols. * Other condition that prevents compliance with postoperative follow-up or rehabilitation protocols. * Current participation in another clinical trial that may interfere with evaluation of this study's outcomes.
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What it tests

  • Robot-assisted closed reduction and internal fixation
  • Conventional manual closed reduction and internal fixation
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Where

1 site
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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