Artificial Intelligence-Assisted vs Surgeon-Planned Trajectories in Freehand Femoral Neck Screw Fixation
NCT ID: NCT06937138
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
334 participants
INTERVENTIONAL
2025-11-14
2027-06-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Orthopedic Intelligent Navigation System in the Treatment of Fresh Femoral Neck Fractures
NCT06713018
Randomized Controlled Clinical Trial of Internal Fixation of Intertrochanteric Fractures of Femur Guided by Conventional Versus IF-AI Artificial Intelligence Program
NCT06195033
Three Cancellous Screws Versus Four Cancellous Screws for Femoral Neck Fixation
NCT04869332
Fixation for the Treatment of Femoral Neck Fractures
NCT03550079
Femoral Neck Locking Plate Vs Multiple Cannulated Cancellous Screws in Treatment of Femoral Neck Fractures in Young Adults: Randomized Controlled Clinical Trial Study
NCT06162637
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
To address these limitations,this trial investigates the effectiveness and safety of artificial intelligence (AI)-assisted versus surgeon-directed screw path planning in freehand percutaneous internal fixation of femoral neck fractures.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
All patients in both groups will undergo the same standardized freehand cannulated screw fixation procedure and will receive uniform perioperative care, rehabilitation guidance, and scheduled follow-up assessments throughout the 12-month study period.
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AI-Assisted Screw Path Planning Group
In the AI-assisted group, the trajectory for screw placement during femoral neck fracture fixation will be guided by an AI algorithm based on intraoperative X-ray imaging. The system will automatically suggest the screw entry point and trajectory, which are displayed for the surgeon to follow during freehand guidewire insertion under fluoroscopy. The surgeon will proceed with the operation after confirming the feasibility of the AI-generated plan. In principle, surgeons are advised not to modify the AI-recommended trajectory unless necessary, to preserve the independent evaluative value of the AI-assisted plan. If significant disagreement arises between the surgeon's judgment and the AI-recommended trajectory, a third-party orthopedic specialist-blinded to group allocation-will conduct an independent postoperative assessment of the screw placement's appropriateness and accuracy.
AI-Assisted Screw Path Planning
The trajectory for screw placement during femoral neck fracture fixation will be guided by an AI algorithm based on intraoperative X-ray imaging. The system will automatically suggest the screw entry point and trajectory, which are displayed for the surgeon to follow during freehand guidewire insertion under fluoroscopy. The surgeon will proceed with the operation after confirming the feasibility of the AI-generated plan. In principle, surgeons are advised not to modify the AI-recommended trajectory unless necessary, to preserve the independent evaluative value of the AI-assisted plan. If significant disagreement arises between the surgeon's judgment and the AI-recommended trajectory, a third-party orthopedic specialist-blinded to group allocation-will conduct an independent postoperative assessment of the screw placement's appropriateness and accuracy.
Surgeon-Directed Screw Path Planning Group
In the surgeon-directed planning group, the screw trajectory will be determined entirely by the operating surgeon, based on personal experience and interpretation of intraoperative fluoroscopy. All decisions regarding the screw entry point and trajectory will be made manually without assistance from the AI planning module.
Surgeon-Directed Screw Path Planning
The screw trajectory will be entirely determined manually by the operating surgeon, based on personal experience and interpretation of intraoperative fluoroscopy, without reliance on any AI recommendation module.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AI-Assisted Screw Path Planning
The trajectory for screw placement during femoral neck fracture fixation will be guided by an AI algorithm based on intraoperative X-ray imaging. The system will automatically suggest the screw entry point and trajectory, which are displayed for the surgeon to follow during freehand guidewire insertion under fluoroscopy. The surgeon will proceed with the operation after confirming the feasibility of the AI-generated plan. In principle, surgeons are advised not to modify the AI-recommended trajectory unless necessary, to preserve the independent evaluative value of the AI-assisted plan. If significant disagreement arises between the surgeon's judgment and the AI-recommended trajectory, a third-party orthopedic specialist-blinded to group allocation-will conduct an independent postoperative assessment of the screw placement's appropriateness and accuracy.
Surgeon-Directed Screw Path Planning
The screw trajectory will be entirely determined manually by the operating surgeon, based on personal experience and interpretation of intraoperative fluoroscopy, without reliance on any AI recommendation module.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Fawwaz Al-Smadi, MD
Medical doctorate student
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Guohui Liu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Bobin Mi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Fawwaz Al-Smadi, MD
Role: PRINCIPAL_INVESTIGATOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Union Hospital, Tongji Medical College, HUST - Jinyinghu International Hospital
Wuhan, , China
Union Hospital, Tongji Medical College, HUST - Main Campus
Wuhan, , China
Union Hospital, Tongji Medical College, HUST - Orthopedic Hospital
Wuhan, , China
Union Hospital, Tongji Medical College, HUST - West Campus
Wuhan, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025.0198-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.