Femoral Neck FracturesNCT06937138
Artificial Intelligence-Assisted vs Surgeon-Planned Trajectories in Freehand Femoral Neck Screw Fixation
A study testing AI-Assisted Screw Path Planning and Surgeon-Directed Screw Path Planning in people with Femoral Neck Fractures, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- AI-Assisted Screw Path Planning and Surgeon-Directed Screw Path Planning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 4 sitesChina
- Study dates
- 14 Nov 2025to 15 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Union Hospital, Tongji Medical College, HUST - Jinyinghu International Hospital
Wuhan
Wu Zhou, 15927351653, Wuzhoutjmu1986@163.com
- Recruiting
Union Hospital, Tongji Medical College, HUST - Main Campus
Wuhan
Guohui Liu, MD. PhD, 13201582339, liuguohui@hust.edu.cn
- Recruiting
Union Hospital, Tongji Medical College, HUST - Orthopedic Hospital
Wuhan
Fawwaz Al-Smadi, +8613037110861, fawazsmadi97@yahoo.com
- Recruiting
Union Hospital, Tongji Medical College, HUST - West Campus
Wuhan
Bobin Mi, MD, PhD, +8615972936067, mibobin@hust.edu.cn
About this study
Official title: Comparison of AI-Assisted vs Surgeon-Planned Trajectories in Freehand Femoral Neck Screw Fixation: A Multicenter Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
Femoral neck fractures, occurring between the femoral head and the base of the femoral neck, are among the most common hip injuries, particularly in the elderly population. While surgical fixation with closed reduction and cannulated screws is a widely accepted standard, challenges such as suboptimal screw placement, prolonged fluoroscopy exposure, and increased risk of complications like nonunion or avascular necrosis persist-largely influenced by surgeon experience and intraoperative variability.
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
- Femoral Neck Fractures
- Being tested
- AI-Assisted Screw Path Planning, Surgeon-Directed Screw Path Planning
- Keywords
- Screw Placement Accuracy, Artificial Intelligence in Surgical Planning, Femoral Neck Fracture
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Assisted Screw Path PlanningProcedure or surgery
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 PlanningProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| AI-Assisted Screw Path Planning Group | Experimental | 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. Receives: Procedure: AI-Assisted Screw Path Planning |
| Surgeon-Directed Screw Path Planning Group | Active comparator | 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. Receives: Procedure: Surgeon-Directed Screw Path Planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Accuracy of Screw Placement
Accuracy of screw placement assessed on standardized anteroposterior and lateral radiographs.
Measured: Postoperative Day 1
Secondary outcomes (7)
Number of Fluoroscopy Exposures
Total number of C-arm fluoroscopy shots used during screw placement will be recorded and compared between groups.
Measured: Intraoperative
Operative Time
Total surgical time will be recorded and compared between the AI-assisted and surgeon-directed groups.
Measured: Intraoperative
Intraoperative Blood Loss (mL)
Blood loss will be estimated intraoperatively and documented for each case.
Measured: Intraoperative
Number of Drilling Attempts
Total number of drilling attempts required to achieve acceptable guidewire placement.
Measured: Intraoperative
Surgeon Workload (NASA-TLX)
Workload evaluated using the NASA Task Load Index, including mental, physical, temporal demand, performance, effort, and frustration subscales.
Measured: Immediately after surgery
Functional Recovery - Harris Hip Score (HHS)
Functional outcomes will be evaluated using the Harris Hip Score. Higher scores indicate better function.
Measured: 3, 6, and 12 months postoperatively
Overall complication rate
Composite rate of postoperative complications, including avascular necrosis, nonunion, delayed union, loss of reduction, screw cut-out, hardware failure, need for reoperation, wound complications, and other surgery-related adverse events.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start14 Nov 2025
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FracturesStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a multicenter, prospective, randomized controlled trial (RCT) designed to evaluate the effectiveness and safety of artificial intelligence (AI)-assisted versus surgeon-directed screw trajectory planning in freehand percutaneous internal fixation of femoral neck fractures. To obtain 266 evaluable patients, a total of 334 participants will be enrolled, accounting for an anticipated 20% dropout rate. Eligible patients will be randomly assigned in a 1:1 ratio to either the AI-assisted screw path planning group (n = 167) or the surgeon-directed screw path planning group (n = 167). 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 334 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fawwaz Al-Smadi, MD, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Guohui Liu, MD, PhD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyBobin Mi, MD, PhD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyFawwaz Al-Smadi, MD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937138
- Sponsor's protocol ID
- 2025.0198-01
- Status last verified
- Nov 2025
- First submitted
- 18 Apr 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) underlying the results of this study will be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of AI-Assisted vs Surgeon-Planned Trajectories in Freehand Femoral Neck Screw Fixation: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06937138
- Acronym / sponsor ID
- 2025.0198-01
- Conditions
- Femoral Neck Fractures
- Keywords
- Screw Placement Accuracy, Artificial Intelligence in Surgical Planning, Femoral Neck Fracture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 334 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Femoral neck fractures, occurring between the femoral head and the base of the femoral neck, are among the most common hip injuries, particularly in the elderly population. While surgical fixation with closed reduction and cannulated screws is a widely accepted standard, challenges such as suboptimal screw placement, prolonged fluoroscopy exposure, and increased risk of complications like nonunion or avascular necrosis persist-largely influenced by surgeon experience and intraoperative variability.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a multicenter, prospective, randomized controlled trial (RCT) designed to evaluate the effectiveness and safety of artificial intelligence (AI)-assisted versus surgeon-directed screw trajectory planning in freehand percutaneous internal fixation of femoral neck fractures. To obtain 266 evaluable patients, a total of 334 participants will be enrolled, accounting for an anticipated 20% dropout rate. Eligible patients will be randomly assigned in a 1:1 ratio to either the AI-assisted screw path planning group (n = 167) or the surgeon-directed screw path planning group (n = 167). 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.
| Arm | Type | Receives |
|---|---|---|
| AI-Assisted Screw Path Planning Group | Experimental | Procedure: AI-Assisted Screw Path PlanningIn 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. |
| Surgeon-Directed Screw Path Planning Group | Active comparator | Procedure: Surgeon-Directed Screw Path PlanningIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-Assisted Screw Path PlanningThe 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. | Procedure or surgery | AI-Assisted Screw Path Planning Group |
| Surgeon-Directed Screw Path PlanningThe 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. | Procedure or surgery | Surgeon-Directed Screw Path Planning Group |
Primary outcome
Radiographic Accuracy of Screw Placement
Time frame: Postoperative Day 1
Accuracy of screw placement assessed on standardized anteroposterior and lateral radiographs.
7 secondary outcomes
Number of Fluoroscopy Exposures
Time frame: Intraoperative
Operative Time
Time frame: Intraoperative
Intraoperative Blood Loss (mL)
Time frame: Intraoperative
Number of Drilling Attempts
Time frame: Intraoperative
Surgeon Workload (NASA-TLX)
Time frame: Immediately after surgery
Functional Recovery - Harris Hip Score (HHS)
Time frame: 3, 6, and 12 months postoperatively
Overall complication rate
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) underlying the results of this study will be made available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guohui Liu, MD, PhD principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Bobin Mi, MD, PhD principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Fawwaz Al-Smadi, MD principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Assisted Screw Path Planning and Surgeon-Directed Screw Path Planning in people with Femoral Neck Fractures, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fawwaz Al-Smadi, MD (+8613037110861, fawazsmadi97@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Accuracy of Screw Placement (time frame: Postoperative Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.