Robot-assisted closed reduction: The 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: The 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.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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)
* Prior complex implants in place or previous surgeries significantly affecting evaluation
* Active infection or severe systemic medical contraindications (unable to tolerate anesthesia/surgery)
* Cognitive impairment, poor compliance, pregnancy, or lactation
* Poor local skin conditions (e.g., obvious blisters, severe soft tissue injury)
* Deemed unsuitable by the investigator (e.g., unable to follow up as planned) or refused randomization/enrollment
Primary outcome measure(s)
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 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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