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NCT07733271

Overview

NCT ID: NCT07733271
Lead Sponsor: Beijing Jishuitan HospitalOTHER
Official Title: 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)
Brief 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.
Conditions: Distal Tibial Fracture

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Central Contacts: Chunpeng Zhao, MD / Chief PhysicianContact
zcpllza2008@163.com+86 18610012704