Clinical trial Recruiting at 4 sites Interventional Ages 18 and up

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.

More Femoral Neck Fractures trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment334 (estimated)
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
Academic / other
Locations4 sites (Wuhan and 3 other locations)
StatusRecruiting
StartedNovember 14, 2025
Main results expectedApril 15, 2027
Study endsJune 15, 2027
Registry record updatedNovember 17, 2025
Trial IDNCT06937138 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.