Robot-assisted closed reduction and fixation for intertrochanteric hip 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 autonomous closed reduction and internal fixation to conventional manual closed reduction and fixation for acute, closed intertrochanteric femoral fractures (AO/OTA 31-A) in adults. The primary aim is to determine if the robotic approach yields more excellent or good bone reduction as measured by low-dose CT and 3D quantification, while also examining intraoperative fluoroscopy exposure. Participants are adults aged 18–80 with fracture requiring closed reduction and proximal femoral intramedullary nailing, recruited at Beijng Jishuitan Hospital with collaboration from Beihang University and Aerospace Center Hospital. Outcomes will include reduction accuracy and safety signals, informing whether robotic assistance offers meaningful advantages over traditional methods.

Why it matters

Who can join: the full rules

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.

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.