Robot-Assisted Closed Reduction and Internal Fixation for Femoral Shaft Fractures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Jishuitan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Open fracture.
Multiple severe trauma requiring immediate priority management.
Asymmetry of the lower limbs.
History of ipsilateral femoral shaft malunion.
Trial design
Design model
Parallel
Treatments tested in this trial
Robot-Assisted Closed Reduction
Procedure/SurgeryPatients 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.
Conventional Closed Reduction
Procedure/SurgeryPatients 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Robot-Assisted Close ReductionExperimental treatment 1 intervention
Group B: Traditional Close ReductionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rate 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 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.
Time frame
From completion of surgery to postoperative low-dose CT assessment, assessed up to 2 weeks after surgerySecondary outcomes
1
Total Operation Time Measured in Minutes
Total operation time will be measured in minutes and defined as the duration from initial skin incision to completion of skin closure.
Time frame
From initial skin incision to completion of skin closure, assessed up to 8 hours2
Intraoperative Blood Loss Measured in Milliliters
The estimated total volume of blood loss during the surgical procedure will be recorded in milliliters.
Time frame
From initial skin incision to completion of skin closure, assessed up to 8 hours3
Change from Baseline in Lower Extremity Functional Scale Score (LEFS)
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.
Time frame
From baseline to 1 month, 3 months, 6 months, and 12 months after surgery4
Change from Baseline in EuroQol 5-Dimension 5-Level Score( EQ-5D-5L)
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.
Time frame
From baseline to 1 month, 3 months, 6 months, and 12 months after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Jishuitan Hospital
Lead sponsor
Beihang University
Collaborator
Aerospace Center Hospital
Collaborator
Source ClinicalTrials.gov