An interventional study of Robot-Assisted Closed Reduction and Conventional Closed Reduction in Femoral Shaft Fractures, Femur Fractures and Femur Fracture, sponsored by Beijing Jishuitan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Beijing Jishuitan Hospital · Not applicable, Interventional, and Treatment
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.
186 studies on the registry are indexed under Femoral Fractures; 38 are open to participants now.
This study's planned enrollment of 80 is above the median of 61 across 114 interventional studies indexed under Femoral Fractures.
Browse Femoral Fractures studies →Beijing Jishuitan Hospital is the lead sponsor of 44 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria：
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in this arm will undergo autonomous closed reduction of the fracture assisted by a robotic system, followed by internal fixation performed by the surgeon.
Procedure: Robot-Assisted Closed Reduction
Patients in this arm will undergo traditional closed reduction (or open reduction if necessary) performed manually by the surgeon, followed by conventional internal fixation.
Procedure: Conventional 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.
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.
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 surgery
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 hours
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 hours
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 surgery
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 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:
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 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 12 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
Time to Radiographic Fracture Union Assessed by Standard X-Ray
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.
Time frame: From completion of surgery to the first documented radiographic evidence of fracture union, assessed up to 12 months after surgery
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 12 months after surgery
Incidence of Intraoperative Complications
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.
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 wound problems or infection, thrombotic events, internal fixation failure, or loss of reduction, will be recorded.
Time frame: From completion of surgery to postoperative complication assessment, assessed up to 12 months after surgery
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Dec 2028, 29 months after the start.
Of 50 non-industry interventional studies with no phase under Femoral Fractures, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 50. This study's planned 29 months is above that.
Counting every sponsor, half of 53 studies reached it within 23 months; a quarter within 9 and three quarters within 50.
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Beijing Jishuitan Hospital