NCT06937138 Artificial Intelligence-Assisted vs Surgeon-Planned Trajectories in Freehand Femoral Neck Screw Fixation
| NCT ID | NCT06937138 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Condition | Femoral Neck Fractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 334 participants |
| Start Date | 2025-11-14 |
| Primary Completion | 2027-04-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 334 participants in total. It began in 2025-11-14 with a primary completion date of 2027-04-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Guohui Liu, MD, PhD
PRINCIPAL INVESTIGATOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Frequently Asked Questions
Who can join the NCT06937138 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Femoral Neck Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06937138 currently recruiting?
Yes, NCT06937138 is actively recruiting participants. Contact the research team at fawazsmadi97@yahoo.com for enrollment information.
Where is the NCT06937138 trial being conducted?
This trial is being conducted at Wuhan, China, Wuhan, China, Wuhan, China, Wuhan, China.
Who is sponsoring the NCT06937138 clinical trial?
NCT06937138 is sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The principal investigator is Guohui Liu, MD, PhD at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The trial plans to enroll 334 participants.