Robot-Assisted Closed Reduction and Internal Fixation for Femoral Shaft Fractures (NCT07738380) | Clinical Trial Compass
RecruitingNot Applicable
Robot-Assisted Closed Reduction and Internal Fixation for Femoral Shaft Fractures
China80 participantsStarted 2026-07-01
Plain-language summary
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, unilateral, closed femoral shaft fractures (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association \[AO/OTA\] classification 32).
Be randomized in a 1:1 ratio to receive either robot-assisted closed reduction or traditional surgeon-performed closed reduction, both followed by internal fixation.
Complete standardized perioperative management and follow-up assessments at 1, 3, 6, and 12 months post-surgery, including functional scales such as the Lower Extremity Functional Scale (LEFS) and the EuroQol Five-Dimensional Five-Level questionnaire (EQ-5D-5L), as well as radiographic imaging to monitor bone healing and potential complications.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of Excellent or Good Closed Fracture Reduction Assessed by Postoperative Low-Dose CT-Based 3D Quantitative Reduction Grading Criteria
Timeframe: From completion of surgery to postoperative low-dose CT assessment, assessed up to 2 weeks after surgery