Robot-Assisted Closed Reduction and Internal Fixation for Distal Femoral Fractures | NCT07738406

NCT07738406

Overview

NCT ID: NCT07738406
Lead Sponsor: Beijing Jishuitan HospitalOTHER
Official Title: Key Technology Research and Development for Intelligent Minimally Invasive Precision Treatment of Fractures (Sub-project 3: A Randomized Controlled Trial of Robot-Assisted Closed Reduction and Internal Fixation for Supracondylar Femoral Fractures)
Brief Summary: 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.
Conditions

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

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)

Exclusion Criteria:

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)

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

Deemed unsuitable by the investigator (e.g., unable to follow up, or extreme obesity severely limiting the surgical or robotic workspace)

Refused randomization or enrollment

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