RecruitingNot ApplicableNCT07733271

Robot-Assisted Closed Reduction and Internal Fixation for Extra-Articular Distal Tibial Fractures

Key Technology Research and Development for Intelligent Minimally Invasive Precision Treatment of Fractures (Sub-project 4: A Randomized Controlled Trial of Robot-Assisted Closed Reduction and Internal Fixation for Distal Tibial Fractures)

Sponsor

Beijing Jishuitan Hospital

Enrollment

60 participants

Start Date

Jul 1, 2026

Study Type

INTERVENTIONAL

Conditions

Tibial Fractures Distal Tibial Fracture

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Robot-assisted closed reduction and a procedure called Traditional surgeon-led reduction for people with distal tibial fracture and tibial fractures. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERobot-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.

PROCEDURETraditional 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.