Actively Recruiting
Comparison of AI-Assisted vs Surgeon-Planned Trajectories in Freehand Femoral Neck Screw Fixation: A Multicenter Randomized Controlled Trial
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-11-17
334
Participants Needed
4
Research Sites
8 weeks
Total Duration
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AI-Summary
What this Trial Is About
This clinical trial focuses on adults diagnosed with femoral neck fractures who are candidates for cannulated screw fixation surgery. It aims to compare the use of artificial intelligence (AI) assistance versus surgeon-directed planning for screw path placement during freehand percutaneous femoral neck fracture fixation. The study explores whether AI guidance can improve accuracy of screw placement, reduce surgical time and fluoroscopy exposure, lower blood loss, decrease surgeon workload, and improve functional recovery while reducing complications. Participants will be randomly assigned to one of two groups: an AI-assisted screw path planning group where an AI system suggests screw entry points and trajectories based on intraoperative X-ray images, and a surgeon-directed planning group where screw placement decisions are made manually by the surgeon. Surgeons in the AI-assisted group will generally follow the AI recommendations unless modifications are necessary. Both groups will receive standard perioperative care and follow-up. During the 12-month follow-up, participants will undergo clinical assessments, imaging studies, and have intraoperative and postoperative data collected, including radiographic accuracy of screw placement on postoperative day 1, fluoroscopy exposures, operative time, blood loss, drilling attempts, surgeon workload, functional recovery scores, and complication rates. These measurements will help determine the impact of AI-assisted planning on surgical precision, patient recovery, and safety outcomes.
CONDITIONS
Brief Title
Artificial Intelligence-Assisted vs Surgeon-Planned Trajectories in Freehand Femoral Neck Screw Fixation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 2 18 years or older
- Radiologically confirmed diagnosis of femoral neck fracture (displaced or non-displaced)
- Scheduled to undergo internal fixation with cannulated screws as initial treatment
- Able to understand study procedures and provide informed consent
- Willing and able to follow postoperative follow-up and rehabilitation instructions
You will not qualify if you...
- Evidence of avascular necrosis of the femoral head on the affected side before surgery
- Unable to tolerate the surgical intervention
- Severe physical illnesses, cognitive problems, or mental health conditions affecting compliance with medical instructions or follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants undergo femoral neck fracture fixation surgery using either AI-assisted or surgeon-directed screw path planning, followed by immediate post-operative observation.
1 surgical visit
Duration - Up to 12 months
Participants are monitored for functional recovery and complications after surgery, including assessments at 3, 6, and 12 months postoperatively.
Visits at 3, 6, and 12 months post-surgery
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
Research Team
F
Fawwaz Al-Smadi, MD
B
Bobin Mi, MD, PhD
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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