Robot-Assisted Closed Reduction and Internal Fixation for Extra-Articular Distal Tibial 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 fracture reduction robot system in treating extra-articular distal tibial fractures. Traditional manual bone setting depends heavily on a surgeon's experience, which can sometimes lead to inconsistent alignment and increased radiation exposure. This clinical trial compares robot-assisted closed reduction against the traditional surgeon-led method. The primary goal is to determine if the robotic system improves the rate of accurate fracture alignment (excellent and good reduction rate) and helps patients recover better.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Unilateral, acute, closed distal tibial fractures (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association AO/OTA 43-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 tibia, or pre-existing deformities significantly affecting rotation/length evaluation
Ipsilateral fractures combined with other sites
Pathological fractures (tumor/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, the fracture is fixed with a distal tibial locking plate via the minimally invasive percutaneous plate osteosynthesis (MIPO) technique.
Traditional surgeon-led reduction
Procedure/SurgeryThe 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 tibial locking plates or intramedullary nails according to the surgeon's choice and standard of care.
Treatment groups
60 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