Clinical Research Directory
Browse clinical research sites, groups, and studies.
Artificial Intelligence-Assisted vs Surgeon-Planned Trajectories in Freehand Femoral Neck Screw Fixation
Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Summary
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.
Official title: Comparison of AI-Assisted vs Surgeon-Planned Trajectories in Freehand Femoral Neck Screw Fixation: A Multicenter Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
334
Start Date
2025-11-14
Completion Date
2027-06-15
Last Updated
2025-11-17
Healthy Volunteers
No
Conditions
Interventions
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 trajectory unless necessary, to preserve the independent evaluative value of the AI-assisted plan. If significant disagreement arises between the surgeon's judgment and the AI-recommended trajectory, a third-party orthopedic specialist-blinded to group allocation-will conduct an independent postoperative assessment of the screw placement's appropriateness and accuracy.
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.
Locations (4)
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