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Robot-Assisted Closed Reduction and Internal Fixation for Femoral Shaft 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 evaluate the safety and efficacy of robot-assisted closed reduction for patients with femoral shaft fractures. The main questions it aims to answer are: Does robot-assisted closed reduction provide a statistically significant improvement in the excellent and good reduction rates compared to conventional surgeon-performed reduction? How do the two reduction methods compare in terms of surgical efficiency, fracture healing, and patient functional outcomes? Researchers will compare the robot-assisted closed reduction group to the conventional surgeon-performed reduction group to see if robot-assisted surgery improves the precision of fracture reduction, stability of alignment, and post-operative functional recovery while minimizing trauma. Participants will: Undergo standardized screening to ensure they meet the inclusion criteria for acute, unilater

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Age 18 to 80 years, inclusive. * Unilateral, acute, closed femoral shaft fracture. * AO/OTA classification 32-A, 32-B, or 32-C femoral shaft fracture. * Time from injury to surgery no more than 21 days. * Ability to walk independently before injury, with or without assistive devices. * Ability to provide written informed consent. Exclusion Criteria: * Open fracture. * Multiple severe trauma requiring immediate priority management. * Asymmetry of the lower limbs. * History of ipsilateral femoral shaft malunion. * History of ipsilateral femoral deformity that significantly affects assessment of - limb rotation or length. * Ipsilateral fracture at another site. * Pathological fracture caused by tumor, metabolic bone disease, or other underlying bone pathology. * Complex hardware from previous ipsilateral surgery. * History of ipsilateral surgery that significantly affects clinical or radiographic evaluation. * Active infection. * Severe underlying medical condition that makes the patient unable to tolerate surgery. * Cognitive impairment that prevents study participation or follow-up. * Poor compliance with study procedures or follow-up. * Pregnancy or lactation. * Judged by the investigators to be unsuitable for enrollment. * Unable to complete the planned follow-up period. * Refusal to undergo randomization. * Refusal to participate in the clinical study.
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What it tests

  • Robot-Assisted Closed Reduction
  • Conventional Closed Reduction
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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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