Robot-assisted closed reduction for femoral shaft 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 to conventional closed reduction for acute unilateral femoral shaft fractures. Participants are adults aged 18 to 80 with AO/OTA 32-A, 32-B, or 32-C fractures and surgery within 21 days. Outcomes include reduction quality, alignment stability, healing, and post-operative function. The study is conducted at Beijing Jishuitan Hospital with collaboration from Beihang University and Aerospace Center Hospital. Safety and efficacy of the robotic approach are evaluated against standard surgeon-performed reduction.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Jishuitan Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Chunpeng Zhao
• 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.