Robot-assisted closed reduction and internal fixation for distal tibial fractures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares a robot-assisted closed reduction technique to traditional manual reduction for extra-articular distal tibial fractures. The primary outcome is the rate of excellent or good fracture reduction, with safety and radiographic outcomes monitored. Participants must have unilateral closed distal tibial fractures and be able to walk independently before injury, with surgery occurring within 21 days of injury. Exclusions include open fractures, multiple traumas, prior deformities, infection, and other contraindications. The study is led by Beijing Jishuitan Hospital with collaboration from Aerospace Center Hospital in Beijing.

Why it matters

Who can join: the full rules

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

Where it's running

• Aerospace Center Hospital
  Beijing, Beijing Municipality, China Recruiting
• Beijing Jishuitan Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Chunpeng Zhao, MD / Chief Physician
• Email: zcpllza2008@163.com
• Phone: +86 18610012704

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.