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

NCT06937138 | Recruiting DMC

• 1 other identifier: 2025.0198-01
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 4

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.

Conditions

Femoral Neck Fractures

Keywords

Screw Placement Accuracy; Artificial Intelligence in Surgical Planning; Femoral Neck Fracture

Outcome Measures

Primary Outcomes (1)

• Radiographic Accuracy of Screw Placement

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

  Postoperative Day 1

Secondary Outcomes (7)

• Number of Fluoroscopy Exposures

  Intraoperative

• Operative Time

  Intraoperative

• Intraoperative Blood Loss (mL)

  Intraoperative

• Number of Drilling Attempts

  Intraoperative

• Surgeon Workload (NASA-TLX)

  Immediately after surgery

Other Outcomes (2)

• Surgeon Confidence Score

  Immediately after surgery

• AI Override / Modification Rate (AI Group Only)

  Intraoperative

Study Arms (2)

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.

Procedure: AI-Assisted Screw Path Planning

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.

Procedure: Surgeon-Directed Screw Path Planning

Interventions

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.

AI-Assisted Screw Path Planning Group

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.

Surgeon-Directed Screw Path Planning Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (4)

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

Wuhan, China

RECRUITING

Union Hospital, Tongji Medical College, HUST - Main Campus

Wuhan, China

RECRUITING

Union Hospital, Tongji Medical College, HUST - Orthopedic Hospital

Wuhan, China

RECRUITING

Union Hospital, Tongji Medical College, HUST - West Campus

Wuhan, China

RECRUITING

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

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

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fawwaz Al-Smadi, MD

CONTACT

+8613037110861; fawazsmadi97@yahoo.com

Bobin Mi, MD, PhD

CONTACT

15972936067; mibobin@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctorate student

Model Details: 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.

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: April 22, 2025
• Study Start: November 14, 2025
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): June 15, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)