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

Официальное название

Comparison of AI-Assisted vs Surgeon-Planned Trajectories in Freehand Femoral Neck Screw Fixation: A Multicenter Randomized Controlled Trial

Обзор

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 planning group to the surgeon-directed planning group to determine whether AI guidance contributes to enhanced surgical precision, reduced intraoperative burden, and improved recovery outcomes. Participants will: Undergo freehand percutaneous internal fixation of femoral neck fractures with either AI-assisted or surgeon-directed screw path planning, Receive standardized perioperative care and follow-up at defined intervals, Be evaluated through clinical assessments, imaging studies, and documentation of intraoperative and postoperative metrics over a 12-month follow-up period.

Подробное описание

Femoral neck fractures, occurring between the femoral head and the base of the femoral neck, are among the most common hip injuries, particularly in the elderly population. While surgical fixation with closed reduction and cannulated screws is a widely accepted standard, challenges such as suboptimal screw placement, prolonged fluoroscopy exposure, and increased risk of complications like nonunion or avascular necrosis persist-largely influenced by surgeon experience and intraoperative variability.

To address these limitations,this trial investigates the effectiveness and safety of artificial intelligence (AI)-assisted versus surgeon-directed screw path planning in freehand percutaneous internal fixation of femoral neck fractures.

Вмешательства

• Процедура AI-Assisted Screw Path Planning
  The trajectory for screw placement during femoral neck fracture fixation will be guided by an AI algorithm based on intraoperative X-ray imaging. The system will automatically suggest the screw entry point and trajectory, which are displayed for the surgeon to follow during freehand guidewire insertion under fluoroscopy. The surgeon will proceed with the operation after confirming the feasibility of the AI-generated plan. In principle, surgeons are advised not to modify the AI-recommended trajec
• Процедура Surgeon-Directed Screw Path Planning
  The screw trajectory will be entirely determined manually by the operating surgeon, based on personal experience and interpretation of intraoperative fluoroscopy, without reliance on any AI recommendation module.

Первичные конечные точки

• Radiographic Accuracy of Screw Placement [Срок оценки: Postoperative Day 1]

Вторичные конечные точки (7)

• Number of Fluoroscopy Exposures [Срок оценки: Intraoperative]
• Operative Time [Срок оценки: Intraoperative]
• Intraoperative Blood Loss (mL) [Срок оценки: Intraoperative]
• Number of Drilling Attempts [Срок оценки: Intraoperative]
• Surgeon Workload (NASA-TLX) [Срок оценки: Immediately after surgery]
• Functional Recovery - Harris Hip Score (HHS) [Срок оценки: 3, 6, and 12 months postoperatively]
• Overall complication rate [Срок оценки: Up to 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 4 центра

• Union Hospital, Tongji Medical College, HUST - Jinyinghu International Hospital — Ухань
• Union Hospital, Tongji Medical College, HUST - Main Campus — Ухань
• Union Hospital, Tongji Medical College, HUST - Orthopedic Hospital — Ухань
• Union Hospital, Tongji Medical College, HUST - West Campus — Ухань

Идентификаторы

NCT: NCT06937138 · 2025.0198-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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