AI-assisted vs surgeon-planned screw paths for freehand femoral neck fixation
Official title: Comparison of AI-Assisted vs Surgeon-Planned Trajectories in Freehand Femoral Neck Screw Fixation: A Multicenter Randomized Controlled Trial
Run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · NCT06937138 · Data updated 2026-11-12
This trial will test whether AI-assisted planning leads to more accurate screw placement, shorter operative time, and less radiation for adults having cannulated screw fixation of femoral neck fractures.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 334 (estimated) |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Academic / other |
| Locations | 4 sites (Wuhan and 3 other locations) |
| Status | Recruiting |
| Started | November 14, 2025 |
| Main results expected | April 15, 2027 |
| Study ends | June 15, 2027 |
| Registry record updated | November 17, 2025 |
| Trial ID | NCT06937138 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with a radiologically confirmed femoral neck fracture who are scheduled for cannulated screw fixation and can provide informed consent and attend follow-up are ideal candidates.
✕Probably not a fit
Patients with preexisting avascular necrosis of the affected femoral head, those who cannot tolerate surgery, or those with severe cognitive or medical conditions limiting follow-up are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with radiologically confirmed femoral neck fractures who are scheduled for percutaneous freehand cannulated screw fixation are assigned to either AI-assisted screw path planning or surgeon-directed planning. Surgeons perform the procedures under fluoroscopic guidance using the assigned planning method and intraoperative metrics like operative time, fluoroscopy exposures, and blood loss are recorded. Radiographic endpoints include measures of screw deviation, tip position, and inter-screw parallelism, and postoperative complications and functional outcomes are tracked during follow-up. The study compares the two groups to see if AI guidance improves technical accuracy, reduces surgeon workload, and affects clinical recovery.
Why it matters
Potential benefit: If successful, AI-assisted planning could improve screw placement accuracy, reduce operative time and radiation exposure, and lower complication rates after femoral neck fixation.
How similar studies have gone: AI and navigation tools have improved implant placement accuracy in other orthopedic applications, but AI specifically applied to freehand femoral neck screw planning is relatively novel with limited prior clinical data.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
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
Study contacts
- Principal investigator: Guohui Liu, MD, PhD — Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study coordinator: Fawwaz Al-Smadi, MD
- Email: fawazsmadi97@yahoo.com
- Phone: +8613037110861
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.