Artificial Intelligence-Assisted vs Surgeon-Planned Trajectories in Freehand Femoral Neck
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
| Condition(s) | Femoral Neck Fractures |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 |
| Who can participate | 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 follo |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Locations | Wuhan, China; Wuhan, China; Wuhan, China; Wuhan, China |
| Start date | 2025-11-14 |
| NCT ID | NCT06937138 |
| Official listing | https://clinicaltrials.gov/study/NCT06937138 |