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Artificial Intelligence-Assisted vs Surgeon-Planned Trajectories in Freehand Femoral Neck Screw Fixation

RecruitingNAAges 18 Years - anyAllUnion Hospital, Tongji Medical College, Huazhong …
NCT06937138 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to compare two different methods of screw path planning-AI-assisted versus surgeon-directed-in freehand percutaneous femoral neck fracture fixation surgery. The study will include adult patients diagnosed with femoral neck fractures who are eligible for cannulated screw fixation under fluoroscopic guidance.The main questions it aims to answer are: Does AI-assisted screw path planning improve the radiographic accuracy of screw placement (screw deviation, tip position, and inter-screw parallelism)? Does AI-assisted planning reduce operative time, number of intraoperative fluoroscopy exposures, intraoperative blood loss (mL) and surgeon workload compared with surgeon-directed planning? Does AI-assisted planning reduce postoperative complications and improve functional outcomes compared to surgeon-directed planning? Researchers will compare the AI-assisted

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years; * Radiologically confirmed diagnosis of femoral neck fracture (displaced or non-displaced); * Scheduled to undergo internal fixation with cannulated screws as the initial treatment strategy during the study period; * Capable of understanding the study procedures and providing informed consent; * Willing and able to adhere to the prescribed postoperative follow-up schedule and rehabilitation instructions. Exclusion Criteria: * Evidence of avascular necrosis of the femoral head on the affected side prior to surgery; * Inability to tolerate the surgical intervention; * Severe physical illnesses, cognitive problems (such as memory loss), or mental health conditions that may impair the ability to comply with medical instructions or attending scheduled follow-up appointments.
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What it tests

  • AI-Assisted Screw Path Planning
  • Surgeon-Directed Screw Path Planning
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Where

4 sites
Union Hospital, Tongji Medical College, HUST - Jinyinghu International Hospital
Wuhan, China
Union Hospital, Tongji Medical College, HUST - Main Campus
Wuhan, China
Union Hospital, Tongji Medical College, HUST - Orthopedic Hospital
Wuhan, China
Union Hospital, Tongji Medical College, HUST - West Campus
Wuhan, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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