Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06937138

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

Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-11-17

334

Participants Needed

4

Research Sites

82 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 9 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 4 locations

1

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

Wuhan, China

Actively Recruiting

2

Union Hospital, Tongji Medical College, HUST - Main Campus

Wuhan, China

Actively Recruiting

3

Union Hospital, Tongji Medical College, HUST - Orthopedic Hospital

Wuhan, China

Actively Recruiting

4

Union Hospital, Tongji Medical College, HUST - West Campus

Wuhan, China

Actively Recruiting

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Research Team

F

Fawwaz Al-Smadi, MD

CONTACT

B

Bobin Mi, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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