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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Femoral Neck Fractures
• Intervention / Treatment: Procedure: AI-Assisted Screw Path Planning; Procedure: Surgeon-Directed Screw Path Planning

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.

• Study Type: Interventional
• Enrollment (Estimated): 334
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bobin Mi, MD, PhD; Phone Number: 15972936067; Email: mibobin@hust.edu.cn
• Study Contact Backup: Name: Fawwaz Al-Smadi, MD; Phone Number: +8613037110861; Email: fawazsmadi97@yahoo.com

Study Locations

• China
  • Wuhan, China
    • Recruiting
    • Union Hospital, Tongji Medical College, HUST - Jinyinghu International Hospital
    • Contact: Wu Zhou; Phone Number: 15927351653; Email: Wuzhoutjmu1986@163.com
  • Wuhan, China
    • Recruiting
    • Union Hospital, Tongji Medical College, HUST - Main Campus
    • Contact: Guohui Liu, MD. PhD; Phone Number: 13201582339; Email: liuguohui@hust.edu.cn
  • Wuhan, China
    • Recruiting
    • Union Hospital, Tongji Medical College, HUST - Orthopedic Hospital
    • Contact: Fawwaz Al-Smadi; Phone Number: +8613037110861; Email: fawazsmadi97@yahoo.com
  • Wuhan, China
    • Recruiting
    • Union Hospital, Tongji Medical College, HUST - West Campus
    • Contact: Bobin Mi, MD, PhD; Phone Number: +8615972936067; Email: mibobin@hust.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AI-Assisted Screw Path Planning Group; 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.	Procedure: 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.
Active Comparator: Surgeon-Directed Screw Path Planning Group; 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Accuracy of Screw Placement	Accuracy of screw placement assessed on standardized anteroposterior and lateral radiographs.	Postoperative Day 1

Secondary Outcome Measures

Outcome Measure	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.	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

Other Outcome Measures

Outcome Measure	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)	Frequency and proportion of cases where the operating surgeon significantly modified or overrode the AI-recommended trajectory, with reasons recorded.	Intraoperative

Collaborators and Investigators

• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
• Investigators: Principal Investigator: 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; Principal Investigator: Fawwaz Al-Smadi, MD, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2025
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): June 15, 2027

Study Registration Dates

• First Submitted: April 18, 2025
• First Submitted That Met QC Criteria: April 18, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Femoral Neck Fracture; Screw Placement Accuracy; Artificial Intelligence in Surgical Planning
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures; Hip Injuries; Hip Fractures; Femoral Neck Fractures
• Other Study ID Numbers: 2025.0198-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) underlying the results of this study will be made available upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No