Robot-assisted closed reduction and fixation for distal femur 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 trial compares robot-assisted closed reduction with traditional surgeon-led reduction for supracondylar femoral fractures (AO/OTA 33-A). The study aims to determine if the robotic system improves anatomical alignment and functional recovery while reducing radiation exposure from fluoroscopy. Participants are adults with acute unilateral closed fractures, eligible if surgery can occur within 21 days and they can walk independently before injury. The trial will assess safety and efficacy of the robotic approach versus conventional fixation. No phase designation is reported.

Why it matters

Who can join: the full rules

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

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.