Femoral Shaft Fractures, Femur Fracture, Femur Fractures
Conditions
Brief 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.
Interventions
PROCEDURERobot-Assisted Closed Reduction
Patients in this group will undergo robotic-assisted closed reduction of the femoral shaft fracture. The procedure utilizes a robotic system for intraoperative navigation and automated reduction planning based on preoperative computed tomography (CT) imaging. The robotic system assists the surgeon in achieving precise fracture alignment. Following successful reduction, routine internal fixation (intramedullary nailing) will be performed by the surgeon.
PROCEDUREConventional Closed Reduction
Patients in this group will undergo traditional manual closed reduction of the femoral shaft fracture. The reduction will be performed by the surgeon using standardized traction and manipulation techniques under real-time fluoroscopic guidance. Following manual reduction, routine internal fixation (intramedullary nailing) will be performed by the surgeon.
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. * 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.
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 CT using a 3D quantitative grading system. Three dimensions will be graded as Excellent, Good, Fair, or Poor: displacement, angular deformity, and rotational deformity. The thresholds are \<=3 mm/degree for Excellent, \>3-5 mm/degree for Good, \>5-10 mm/degree for Fair, and \>10 mm/degree for Poor. The final grade will be the lowest grade across the three 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 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. |
| Change from Baseline in Lower Extremity Functional Scale Score (LEFS) | From baseline to 1 month, 3 months, 6 months, and 12 months after surgery | Lower extremity function will be evaluated using the Lower Extremity Functional Scale (LEFS). The LEFS consists of 20 items concerning activities of daily living, each scored from 0 to 4 (0=extreme difficulty/unable to perform; 4=no difficulty). The total score ranges from 0 to 80 points; higher scores indicate better functional ability. |
| Change from Baseline in EuroQol 5-Dimension 5-Level Score( EQ-5D-5L) | From baseline to 1 month, 3 months, 6 months, and 12 months after surgery | Health-related quality of life will be evaluated using the EuroQol Five-Dimensional Five-Level questionnaire (EQ-5D-5L). It assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scores are converted into an index value, where higher values indicate a better quality of life. |
| 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. Time Frame: |
| 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 Reoperation | From completion of surgery to reoperation assessment, assessed up to 12 months after surgery | The percentage of participants requiring reoperation after the index surgery 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. |
| Time to Radiographic Fracture Union Assessed by Standard X-Ray | From completion of surgery to the first documented radiographic evidence of fracture union, assessed up to 12 months after surgery | Time to radiographic fracture union will be measured in weeks using standard anteroposterior and lateral X-rays. Fracture union is defined as cortical bridging in at least 3 of 4 cortices with no significant pain during weight-bearing. Low-dose CT may be used to confirm fracture union in uncertain cases. |
| 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 12 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 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, cortical perforation, abnormal bleeding, device failure, registration failure requiring manual takeover or change of reduction strategy, will be recorded. |
| Incidence of Postoperative Complications | From completion of surgery to postoperative complication assessment, assessed up to 12 months after surgery | The percentage of participants experiencing postoperative complications, including wound problems or infection, thrombotic events, internal fixation failure, or loss of reduction, will be recorded. |
Countries
China
Contacts
CONTACTChunpeng Zhao
Outcome results
None listed