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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
334
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.
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.
Union Hospital, Tongji Medical College, HUST - Jinyinghu International Hospital
Wuhan, China
RECRUITINGUnion Hospital, Tongji Medical College, HUST - Main Campus
Wuhan, China
RECRUITINGUnion Hospital, Tongji Medical College, HUST - Orthopedic Hospital
Wuhan, China
RECRUITINGUnion Hospital, Tongji Medical College, HUST - West Campus
Wuhan, China
RECRUITINGRadiographic Accuracy of Screw Placement
Accuracy of screw placement assessed on standardized anteroposterior and lateral radiographs.
Time frame: Postoperative Day 1
Number of Fluoroscopy Exposures
Total number of C-arm fluoroscopy shots used during screw placement will be recorded and compared between groups.
Time frame: Intraoperative
Operative Time
Total surgical time will be recorded and compared between the AI-assisted and surgeon-directed groups.
Time frame: Intraoperative
Intraoperative Blood Loss (mL)
Blood loss will be estimated intraoperatively and documented for each case.
Time frame: Intraoperative
Number of Drilling Attempts
Total number of drilling attempts required to achieve acceptable guidewire placement.
Time frame: Intraoperative
Surgeon Workload (NASA-TLX)
Workload evaluated using the NASA Task Load Index, including mental, physical, temporal demand, performance, effort, and frustration subscales.
Time frame: Immediately after surgery
Functional Recovery - Harris Hip Score (HHS)
Functional outcomes will be evaluated using the Harris Hip Score. Higher scores indicate better function.
Time frame: 3, 6, and 12 months postoperatively
Overall complication rate
Composite rate of postoperative complications, including avascular necrosis, nonunion, delayed union, loss of reduction, screw cut-out, hardware failure, need for reoperation, wound complications, and other surgery-related adverse events.
Time frame: Up to 12 months
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