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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI-Assisted Screw Path Planning Group | Experimental | In the AI-assisted group, 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 Group | Active Comparator | In the surgeon-directed planning group, the screw trajectory will be determined entirely by the operating surgeon, based on personal experience and interpretation of intraoperative fluoroscopy. All decisions regarding the screw entry point and trajectory will be made manually without assistance from the AI planning module. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-Assisted Screw Path Planning | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Accuracy of Screw Placement | Accuracy of screw placement assessed on standardized anteroposterior and lateral radiographs. | Postoperative Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Fluoroscopy Exposures | Total number of C-arm fluoroscopy shots used during screw placement will be recorded and compared between groups. | Intraoperative |
| Operative Time | Total surgical time will be recorded and compared between the AI-assisted and surgeon-directed groups. |
| Measure | Description | Time Frame |
|---|---|---|
| Surgeon Confidence Score | Surgeon self-reported confidence in the trajectory planning and screw placement accuracy measured using a 5-point Likert scale. | Immediately after surgery |
| AI Override / Modification Rate (AI Group Only) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fawwaz Al-Smadi, MD | Contact | +8613037110861 | fawazsmadi97@yahoo.com | |
| Bobin Mi, MD, PhD | Contact | 15972936067 | mibobin@hust.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Guohui Liu, MD, PhD | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Principal Investigator |
| Bobin Mi, MD, PhD | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital, Tongji Medical College, HUST - Jinyinghu International Hospital | Recruiting | Wuhan | China |
Individual participant data (IPD) underlying the results of this study will be made available upon reasonable request.
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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.
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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.
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| Surgeon-Directed Screw Path Planning | Procedure | 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. |
|
| Intraoperative |
| Intraoperative Blood Loss (mL) | Blood loss will be estimated intraoperatively and documented for each case. | Intraoperative |
| Number of Drilling Attempts | Total number of drilling attempts required to achieve acceptable guidewire placement. | Intraoperative |
| Surgeon Workload (NASA-TLX) | Workload evaluated using the NASA Task Load Index, including mental, physical, temporal demand, performance, effort, and frustration subscales. | Immediately after surgery |
| Functional Recovery - Harris Hip Score (HHS) | Functional outcomes will be evaluated using the Harris Hip Score. Higher scores indicate better function. | 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. | Up to 12 months |
Frequency and proportion of cases where the operating surgeon significantly modified or overrode the AI-recommended trajectory, with reasons recorded.
| Intraoperative |
| Fawwaz Al-Smadi, MD | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Principal Investigator |
| Union Hospital, Tongji Medical College, HUST - Main Campus | Recruiting | Wuhan | China |
|
| Union Hospital, Tongji Medical College, HUST - Orthopedic Hospital | Recruiting | Wuhan | China |
|
| Union Hospital, Tongji Medical College, HUST - West Campus | Recruiting | Wuhan | China |
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| ID | Term |
|---|---|
| D005265 | Femoral Neck Fractures |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
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