Robot-Assisted Closed Reduction and Internal Fixation for Intertrochanteric Femoral Fractures (NCT07738458) | Clinical Trial Compass
RecruitingNot Applicable
Robot-Assisted Closed Reduction and Internal Fixation for Intertrochanteric Femoral Fractures
China60 participantsStarted 2026-07-01
Plain-language summary
The goal of this clinical trial is to compare the clinical effectiveness and safety of robot-assisted autonomous closed reduction versus traditional manual closed reduction in adult patients aged 18 to 80 years with acute, closed intertrochanteric femoral fractures (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association \[AO/OTA\] classification 31-A). The main question it aims to answer is:
Whether robot-assisted autonomous closed reduction can achieve a significantly higher rate of excellent and good bone fracture reduction compared to traditional manual reduction, as rigorously evaluated by low-dose computed tomography (CT) and a three-dimensional (3D) quantitative standard.
Researchers will compare the robot-assisted autonomous closed reduction group (intervention group) to the traditional manual closed reduction group (control group) to see if the robotic system significantly improves 3D anatomical reduction precision, reduces intraoperative fluoroscopy times and radiation doses, shortens operation times, and ultimately enhances long-term clinical hip functions and health-related quality of life.
Participants will be asked to do the following tasks:
Complete baseline medical screening, standard hip X-rays, and bilateral full-length thin-layer CT scans before the surgery.
Undergo a 1:1 randomized allocation after anesthesia to receive either robot-assisted autonomous closed reduction or traditional experience-based manual closed reduction, both followed by conventional proximal femoral intramedullary nailing internal fixation.
Receive post-operative low-dose CT scans before discharge or within 2 weeks after surgery to evaluate the fracture reduction quality.
Follow a standardized Enhanced Recovery After Surgery (ERAS) rehabilitation pathway and attend scheduled follow-up visits at 1, 3, and 6 months after the surgery to monitor bone healing, hip functions, and quality of life
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.
* 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 …
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