AI-assisted vs surgeon-planned screw paths for freehand femoral neck fixation
Comparison of AI-Assisted vs Surgeon-Planned Trajectories in Freehand Femoral Neck Screw Fixation: A Multicenter Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 334 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Academic / other |
| Locations | 4 sites (Wuhan and 3 other locations) |
| Trial ID | NCT06937138 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Wuhan and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.