Femoral Neck Fractures
Conditions
Keywords
Screw Placement Accuracy, Artificial Intelligence in Surgical Planning, Femoral Neck Fracture
Brief 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.
Detailed description
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.
Interventions
PROCEDUREAI-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.
PROCEDURESurgeon-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.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
In addition to outcome assessors, third-party orthopedic specialists responsible for postoperative evaluation of screw trajectory accuracy will also be masked to group allocation. These blinded experts will independently assess the appropriateness and accuracy of screw placement in cases where discrepancies arise between AI-recommended and surgeon-modified trajectories. This masking ensures objective evaluation and minimizes assessment bias in the radiographic analysis of screw positioning.
Intervention model description
This study is a multicenter, prospective, randomized controlled trial (RCT) designed to evaluate the effectiveness and safety of artificial intelligence (AI)-assisted versus surgeon-directed screw trajectory planning in freehand percutaneous internal fixation of femoral neck fractures. To obtain 266 evaluable patients, a total of 334 participants will be enrolled, accounting for an anticipated 20% dropout rate. Eligible patients will be randomly assigned in a 1:1 ratio to either the AI-assisted screw path planning group (n = 167) or the surgeon-directed screw path planning group (n = 167). All patients in both groups will undergo the same standardized freehand cannulated screw fixation procedure and will receive uniform perioperative care, rehabilitation guidance, and scheduled follow-up assessments throughout the 12-month study period.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Accuracy of Screw Placement | Postoperative Day 1 | Accuracy of screw placement assessed on standardized anteroposterior and lateral radiographs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Blood Loss (mL) | Intraoperative | Blood loss will be estimated intraoperatively and documented for each case. |
| Number of Fluoroscopy Exposures | Intraoperative | Total number of C-arm fluoroscopy shots used during screw placement will be recorded and compared between groups. |
| Operative Time | Intraoperative | Total surgical time will be recorded and compared between the AI-assisted and surgeon-directed groups. |
| Number of Drilling Attempts | Intraoperative | Total number of drilling attempts required to achieve acceptable guidewire placement. |
| Functional Recovery - Harris Hip Score (HHS) | 3, 6, and 12 months postoperatively | Functional outcomes will be evaluated using the Harris Hip Score. Higher scores indicate better function. |
| Overall complication rate | Up to 12 months | 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. |
| Surgeon Workload (NASA-TLX) | Immediately after surgery | Workload evaluated using the NASA Task Load Index, including mental, physical, temporal demand, performance, effort, and frustration subscales. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Surgeon Confidence Score | Immediately after surgery | Surgeon self-reported confidence in the trajectory planning and screw placement accuracy measured using a 5-point Likert scale. |
| AI Override / Modification Rate (AI Group Only) | Intraoperative | Frequency and proportion of cases where the operating surgeon significantly modified or overrode the AI-recommended trajectory, with reasons recorded. |
Countries
China
Contacts
Primary ContactFawwaz Al-Smadi, MD
Backup ContactBobin Mi, MD, PhD
Outcome results
None listed