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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
The key distinguishing feature of this intervention is the transition from empirical, experience-based traction to computer-planned, quantitatively-controlled reduction. The robotic system creates an individualized 3D model based on pre-operative thin-layer CT and automatically calculates precise fragment displacement parameters. Unlike manual methods, the reduction pathway is executed or guided via real-time spatial navigation and digital monitoring with strict safety interlocking mechanisms. This approach aims to reduce human judgment bias and enhance 3D anatomical alignment precision, particularly in correcting complex translation and rotational deformities.
This intervention relies entirely on the surgical team's clinical experience, using a standard orthopedic traction table or manual manipulation to achieve bone alignment. Unlike the experimental group, no intelligent robotic systems, 2D-3D registration software, or spatial tracking devices are permitted during any stage of the operation. Reduction quality is evaluated intraoperatively using routine two-dimensional C-arm fluoroscopy (AP and lateral views) rather than computerized 3D planning. If closed alignment is inadequate, the surgeon may convert to a limited open reduction using joysticks or clamps based on empirical judgment.
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, China
RECRUITINGRate of Excellent or Good Closed Fracture Reduction Assessed by Postoperative Low-Dose CT-Based 3D Quantitative Reduction Grading Criteria
Closed fracture reduction will be assessed on postoperative low-dose CT using a 3D quantitative grading system. Four dimensions will be graded as Excellent, Good, Fair, or Poor: displacement/shortening, angular deformity, rotational deformity, and medial/anterior cortical support. The thresholds are ≤3 mm/° for Excellent, \>3-5 mm/° for Good, \>5-10 mm/° for Fair, and \>10 mm/° for Poor, while cortical support is graded as positive, neutral, mild negative, or significant negative/step-off. The final grade will be the lowest grade across all dimensions, and the excellent/good rate is the percentage of participants with a final grade of Excellent or Good.
Time frame: From completion of surgery to postoperative low-dose CT assessment, assessed up to 2 weeks after surgery
Total Operation Time Measured in Minutes
Total operation time will be measured in minutes and defined as the duration from the initial skin incision to completion of skin closure.
Time frame: From initial skin incision to completion of skin closure, assessed up to 8 hours
Intraoperative Blood Loss Measured in Milliliters
The estimated total volume of blood loss during the surgical procedure will be recorded in milliliters (mL).
Time frame: From initial skin incision to completion of skin closure, assessed up to 8 hours
Change from Baseline in Hip Function Assessed by Harris Hip Score (HHS)
Hip function will be evaluated using the Harris Hip Score (HHS). The score ranges from 0 to 100 points, evaluating domains including pain, daily functions (gait, activities of daily living), absence of deformity, and joint range of motion. A higher score indicates better hip function and lower pain severity.
Time frame: From baseline to 1 month, 3 months, and 6 months after surgery
Change from Baseline in Quality of Life Assessed by EQ-5D-5L Questionnaire
Health-related quality of life will be evaluated using the EuroQol Five-Dimensional Five-Level questionnaire (EQ-5D-5L). It measures five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Descriptive scores are converted into a standard index value, where higher values mean better health status.
Time frame: From baseline to 1 month, 3 months, and 6 months after surgery
Time to Radiographic Bone Healing Assessed by Standard Two-View X-Ray
Time to radiographic bone healing will be measured in weeks. Radiographic bone healing will be defined as cortical bridging in at least 3 of 4 cortices on standard anteroposterior and lateral X-rays, with no significant pain during weight-bearing. Low-dose CT may be used to confirm bone healing in uncertain cases.
Time frame: From completion of surgery to the first documented radiographic evidence of fracture union, assessed up to 6 months after surgery
Number of Intraoperative C-Arm Fluoroscopy Shots
The number of intraoperative fluoroscopy shots taken using the C-arm during the surgical procedure will be recorded.
Time frame: From initial skin incision to completion of skin closure, assessed up to 8 hours
Robot-Assisted Reduction Planning and Execution Time Measured in Minutes in the Experimental Group
For participants assigned to the experimental group, the robot-assisted reduction planning and execution time will be recorded in minutes. This time is defined as the duration from completion of robotic arm setup to completion of the reduction maneuver.
Time frame: From initial skin incision to completion of the reduction maneuver, assessed up to 8 hours
Incidence of Intraoperative Complications
The percentage of participants experiencing intraoperative complications, including neurovascular injury, device failure, or conversion to manual reduction, will be recorded.
Time frame: From initial skin incision to completion of skin closure, assessed up to 8 hours
Incidence of Postoperative Complications
The percentage of participants experiencing postoperative complications, including surgical site infection, deep vein thrombosis, implant loosening or breakage, screw cut-out, or femoral head collapse, will be recorded.
Time frame: From completion of surgery to the occurrence of postoperative complications, assessed up to 6 months after surgery
Length of Hospital Stay Measured in Days
The length of hospital stay will be recorded in days from admission to hospital discharge.
Time frame: From hospital admission to hospital discharge, assessed up to 30 days
Radiographic Fracture Union Rate Assessed by Standard X-Ray
The percentage of participants achieving radiographic fracture union will be assessed using standard anteroposterior and lateral X-rays. Low-dose CT may be used to confirm fracture union in uncertain cases.
Time frame: From completion of surgery to the first documented radiographic evidence of fracture union, assessed up to 6 months after surgery
Incidence of Reoperation
The percentage of participants requiring reoperation after the index surgery will be recorded.
Time frame: From completion of surgery to reoperation assessment, assessed up to 6 months after surgery
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