Clinical trial NCT06937138: Artificial Intelligence-Assisted vs Surgeon-Directed Screw Planning in Robotic Femoral Neck Fracture Surgery
Official title: Comparison of AI-Assisted vs Surgeon-Directed Screw Path Planning in Robotic-Assisted Femoral Neck Fracture Fixation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Femoral Neck Fractures
Keywords: Robotic-Assisted Orthopedic Surgery
Screw Placement Accuracy
Artificial Intelligence in Surgical Planning
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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 robotic-assisted internal fixation of femoral neck fractures. A total of 120 eligible patients will be enrolled and randomly assigned in a 1:1 ratio to either the AI-assisted screw path planning group (n = 60) or the surgeon-directed screw path planning group (n = 60). All patients in both groups will receive the same standardized postoperative care, rehabilitation guidance, and follow-up assessments.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare two different methods of screw path planning-AI-assisted versus surgeon-directed-in robotic-assisted femoral neck fracture fixation surgery. The study will include adult patients diagnosed with femoral neck fractures who are eligible for surgical fixation using a robotic system. The main questions it aims to answer are:

Does AI-assisted screw path planning improve the radiographic accuracy of screw placement? Does AI-assisted planning reduceoperative time, number of intraoperative fluoroscopy exposures, intraoperative blood loss (mL)? 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 operative risk, and improved recovery outcomes.

Participants will:

Undergo robotic-assisted 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 6-month follow-up period.

Detailed description: Femoral neck fractures, occurring between the femoral head and neck base, 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 robotic-assisted internal fixation of femoral neck fractures.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years;
* Radiologically confirmed diagnosis of femoral neck fracture (displaced or non-displaced);
* Scheduled to undergo robotic-assisted 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.

Primary outcomes:
measure: Radiographic Accuracy of Screw Placement
timeFrame: Postoperative Day 1
Secondary outcomes:
measure: Number of Fluoroscopy Exposures
timeFrame: Intraoperative
measure: Operative Time
timeFrame: Intraoperative
measure: Intraoperative Blood Loss (mL)
timeFrame: Intraoperative
measure: Functional Recovery - Harris Hip Score (HHS)
timeFrame: At 6 months postoperatively
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: Guohui Liu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuhan Union Hospital, China
name: Bobin Mi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuhan Union Hospital, China
name: Fawwaz O. Al-Smadi, MD
role: PRINCIPAL_INVESTIGATOR
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