Intertrochanteric Fractures, Intertrochanteric Fractures of the Femur, Intertrochanteric Fractures of the Hip
Conditions
Brief 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
Interventions
PROCEDURERobot-assisted closed reduction and internal fixation
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.
PROCEDUREConventional manual closed reduction and internal fixation
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.
Sponsors
Beijing Jishuitan Hospital
Beihang University
Aerospace Center Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Excellent or Good Closed Fracture Reduction Assessed by Postoperative Low-Dose CT-Based 3D Quantitative Reduction Grading Criteria | From completion of surgery to postoperative low-dose CT assessment, assessed up to 2 weeks after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Operation Time Measured in Minutes | From initial skin incision to completion of skin closure, assessed up to 8 hours | Total operation time will be measured in minutes and defined as the duration from the initial skin incision to completion of skin closure. |
| Intraoperative Blood Loss Measured in Milliliters | From initial skin incision to completion of skin closure, assessed up to 8 hours | The estimated total volume of blood loss during the surgical procedure will be recorded in milliliters (mL). |
| Change from Baseline in Hip Function Assessed by Harris Hip Score (HHS) | From baseline to 1 month, 3 months, and 6 months after surgery | 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. |
| Change from Baseline in Quality of Life Assessed by EQ-5D-5L Questionnaire | From baseline to 1 month, 3 months, and 6 months after surgery | 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 to Radiographic Bone Healing Assessed by Standard Two-View X-Ray | From completion of surgery to the first documented radiographic evidence of fracture union, assessed up to 6 months after surgery | 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. |
| Number of Intraoperative C-Arm Fluoroscopy Shots | From initial skin incision to completion of skin closure, assessed up to 8 hours | The number of intraoperative fluoroscopy shots taken using the C-arm during the surgical procedure will be recorded. |
| Robot-Assisted Reduction Planning and Execution Time Measured in Minutes in the Experimental Group | From initial skin incision to completion of the reduction maneuver, assessed up to 8 hours | 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. |
| Incidence of Intraoperative Complications | From initial skin incision to completion of skin closure, assessed up to 8 hours | The percentage of participants experiencing intraoperative complications, including neurovascular injury, device failure, or conversion to manual reduction, will be recorded. |
| Incidence of Postoperative Complications | From completion of surgery to the occurrence of postoperative complications, assessed up to 6 months after surgery | 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. |
| Length of Hospital Stay Measured in Days | From hospital admission to hospital discharge, assessed up to 30 days | The length of hospital stay will be recorded in days from admission to hospital discharge. |
| Radiographic Fracture Union Rate Assessed by Standard X-Ray | From completion of surgery to the first documented radiographic evidence of fracture union, assessed up to 6 months after surgery | 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. |
| Incidence of Reoperation | From completion of surgery to reoperation assessment, assessed up to 6 months after surgery | The percentage of participants requiring reoperation after the index surgery will be recorded. |
Countries
China
Contacts
CONTACTChunpeng Zhao
Outcome results
None listed