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NCT Number: NCT06937138

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

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.

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Key information

Conditions

Femoral Neck Fractures Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Union Hospital, Tongji Medical College, HUST - Jinyinghu International Hospital, Wuhan, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Radiographic Accuracy of Screw Placement

    Time frame: Postoperative Day 1

    Accuracy of screw placement assessed on standardized anteroposterior and lateral radiographs.

Secondary outcomes

  1. Number of Fluoroscopy Exposures

    Time frame: Intraoperative

    Total number of C-arm fluoroscopy shots used during screw placement will be recorded and compared between groups.

  2. Operative Time

    Time frame: Intraoperative

    Total surgical time will be recorded and compared between the AI-assisted and surgeon-directed groups.

  3. Intraoperative Blood Loss (mL)

    Time frame: Intraoperative

    Blood loss will be estimated intraoperatively and documented for each case.

  4. Number of Drilling Attempts

    Time frame: Intraoperative

    Total number of drilling attempts required to achieve acceptable guidewire placement.

  5. Surgeon Workload (NASA-TLX)

    Time frame: Immediately after surgery

    Workload evaluated using the NASA Task Load Index, including mental, physical, temporal demand, performance, effort, and frustration subscales.

  6. Functional Recovery - Harris Hip Score (HHS)

    Time frame: 3, 6, and 12 months postoperatively

    Functional outcomes will be evaluated using the Harris Hip Score. Higher scores indicate better function.

  7. Overall complication rate

    Time frame: 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.

Other outcomes

  1. Surgeon Confidence Score

    Time frame: Immediately after surgery

    Surgeon self-reported confidence in the trajectory planning and screw placement accuracy measured using a 5-point Likert scale.

  2. AI Override / Modification Rate (AI Group Only)

    Time frame: Intraoperative

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

Study contacts

Contact information is provided by the study sponsor or research team.

Bobin Mi, MD, PhD

CONTACT

[email protected]

15972936067

Fawwaz Al-Smadi, MD

CONTACT

[email protected]

+8613037110861

Sponsors and collaborators

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 22, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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