Robot-Assisted Closed Reduction and Internal Fixation for Distal Femoral Fractures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Jishuitan Hospital
About this trial
This study aims to evaluate the clinical efficacy and safety of an intelligent robotic system for the closed reduction of extra-articular supracondylar femoral fractures (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association AO/OTA 33-A). Traditional manual reduction for supracondylar femoral fractures is often challenging due to strong muscle pull, heavily relying on the surgeon's experience and frequently requiring repeated fluoroscopy. This clinical trial compares robot-assisted closed reduction against traditional surgeon-led reduction methods. The primary goal is to determine if the robotic system improves the precision of bone alignment (excellent and good reduction rate) and functional recovery while reducing surgical radiation exposure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 80 years old
Unilateral, acute, closed extra-articular supracondylar femoral fracture (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association AO/OTA 33-A)
Time from injury to surgery ≤21 days
Able to walk independently before injury (assistive devices allowed)
Disqualifiers
Open fractures or multiple severe traumas requiring priority treatment
Asymmetrical lower extremities, or prior malunion of the ipsilateral femur, or pre-existing deformities significantly affecting rotation/length evaluation
Unilateral fractures combined with other sites
Pathological fractures (tumor or metabolic)
Trial design
Design model
Parallel
Treatments tested in this trial
Robot-assisted closed reduction
DeviceThe patient undergoes automated or human-robot collaborative closed fracture reduction powered by an intelligent robotic system. The system integrates deep-learning-based bone segmentation, automatic reduction planning, and a self-adaptive 2D-3D image registration framework to achieve sub-millimeter positioning feedback and force-position collaborative security gates. Following successful reduction, internal fixation is performed using a distal femoral locking compression plate (LCP-DF) via the minimally invasive percutaneous plate osteosynthesis (MIPO) technique.
Conventional fracture reduction and internal fixation
DeviceThe patient undergoes conventional closed or open fracture reduction performed entirely by the surgical team based on traditional clinical experience under ordinary C-arm fluoroscopic guidance. Internal fixation is achieved using standard distal femoral locking plates or intramedullary nails (with dual-plate fixation permitted when indicated for medial bone defects or collapse) according to the surgeon's choice and standard of care.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Robot-Assisted GroupExperimental treatment 1 intervention
Group B: Traditional GroupActive 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
The percentage of patients achieving "Excellent" or "Good" anatomical closed reduction. Reduction quality is measured on post-op CT via RadiAnt DICOM Viewer and 3D Slicer based on the worst-performing of 3 dimensions: 1. Separation/shortening displacement: Excellent (≤3mm), Good (\>3-5mm), Fair (\>5-10mm), Poor (\>10mm). 2. Angulation deformity: Excellent (≤3°), Good (\>3-5°), Fair (\>5-10°), Poor (\>10°). 3. Rotational deformity: Excellent (≤3°), Good (\>3-5°), Fair (\>5-10°), Poor (\>10°). The final reduction grade is determined by the lowest category among these parameters, and the primary outcome represents the proportion of patients graded as 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
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 hours3
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 hours4
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 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Jishuitan Hospital
Lead sponsor
Aerospace Center Hospital
Collaborator
Source ClinicalTrials.gov