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CompletedNCT07737223FAIS-AIUpdated Jul 30, 2026

AI-Based Screening and Diagnostic Models for Femoroacetabular Impingement Syndrome (FAIS-AI)

An observational study in Femoroacetabular Impingement Syndrome, sponsored by ChunBao Li. Completed at 1 site in China. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by ChunBao Li · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
2,617
Ages
12 Years and older
Sex
All
01

Study summary

Femoroacetabular impingement syndrome (FAIS) is the leading cause of hip pain in young adults and frequently progresses to osteoarthritis, often exacerbated by delayed diagnosis in primary care. Current AI models for FAIS diagnosis primarily rely on single imaging modalities, limiting their diagnostic accuracy and clinical utility.

This multicenter, retrospective-prospective study aims to develop and validate AI-based screening and diagnostic models for FAIS by integrating multimodal clinical features and pelvic radiographic data. A retrospective cohort of 1,841 patients (January 2019 to January 2025) was collected from four tertiary centers in Beijing (First and Fourth Medical Centers of PLA General Hospital, Beijing Friendship Hospital, and Rocket Force Characteristic Medical Center) for model development and internal validation. A screening model was built using the 10 most contributory clinical features (identified via SHAP analysis from 47 consensus-based features) with a fully connected neural network. A diagnostic model was built by combining clinical features, automated hip radiographic measurements (CE Angle, Tonnis Angle, Alpha Angle, Femoral Neck-Shaft Angle via CenterNet), and hip X-ray images (via YOLOv8 + CNN) through a dual-channel hybrid deep learning architecture. Prospective external validation was performed on an independent cohort of 776 patients from four population groups (large hospital, athletic, student, community) between February and November 2025. Model performance was evaluated using AUC, sensitivity, specificity, accuracy, PPV, NPV, and decision curve analysis, and compared against five physicians of varying seniority. The study aims to address FAIS diagnostic delays by providing an AI-based solution suitable for patient self-assessment, primary care screening, and specialist referral decision-making.

02

Conditions studied

  • Femoroacetabular Impingement Syndrome

Keywords

  • Femoroacetabular Impingement
  • FAIS
  • Artificial Intelligence
  • Deep Learning
  • Hip Pain
  • Screening Model
  • Diagnostic Model
  • Pelvic Radiograph
  • Neural Network
  • YOLOv8
  • Convolutional Neural Network
  • CenterNet
  • SHAP
  • Hip X-ray
03

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients aged 12 years and older who presented with hip pain and underwent hip X-ray examination at the participating institutions between January 2019 and November 2025.

Inclusion criteria

Patients presenting to the outpatient clinic with a chief complaint of hip pain

Meeting preliminary clinical suspicion of hip pathology (based on history and physical examination)

Willing and able to provide written informed consent

Exclusion criteria

Exclusion Criteria:

Groin or thigh hematoma, or abdominal/pelvic masses (identified on physical examination or imaging)

Non-musculoskeletal conditions causing hip-region pain (e.g., urinary tract disorders, gynecological conditions)

Signs of active infection (fever with elevated C-reactive protein)

Incomplete or substandard clinical or imaging data (e.g., poor-quality radiographs, missing key variables)

04

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
2,617 participants (actual)
Patient registry
No

Groups and cohorts

  • FAIS Group

    Patients diagnosed with Femoroacetabular Impingement Syndrome based on clinical and radiographic criteria.

  • Non-FAIS Control Group

    Patients presenting with hip pain who do not meet diagnostic criteria for FAIS.

05

What researchers measure

Primary outcomes

  1. Area Under the Receiver Operating Characteristic Curve (AUC) of the AI screening model for identifying FAIS

    The AI screening model integrates 10 key clinical features identified through SHAP analysis using a fully connected neural network. AUC will be calculated from the receiver operating characteristic (ROC) curve, with values ranging from 0.5 (no discrimination) to 1.0 (perfect discrimination), to evaluate the screening model diagnostic performance.

    Time frame: Through study completion, up to 7 years

  2. Area Under the Receiver Operating Characteristic Curve (AUC) of the AI diagnostic model for identifying FAIS

    The AI diagnostic model combines clinical features, automated hip radiographic measurements (CE Angle, Tonnis Angle, Alpha Angle, Femoral Neck-Shaft Angle via CenterNet), and hip X-ray images (via YOLOv8 + CNN) through a dual-channel hybrid deep learning architecture. AUC will be calculated from the ROC curve to evaluate the comprehensive diagnostic performance.

    Time frame: Through study completion, up to 7 years

Secondary outcomes

  1. Sensitivity, Specificity, Positive Predictive Value (PPV), and Negative Predictive Value (NPV) of the AI screening and diagnostic models

    Sensitivity, specificity, PPV, and NPV will be calculated at the optimal threshold determined from the ROC curve analysis (Youden index). These metrics provide clinically meaningful measures of the models diagnostic accuracy for FAIS detection in real-world clinical settings.

    Time frame: Through study completion, up to 7 years

  2. Net benefit of the AI models in Decision Curve Analysis (DCA)

    Decision curve analysis will be performed to assess the clinical net benefit of the AI screening and diagnostic models across a range of threshold probabilities. This analysis evaluates whether using the AI models for clinical decision-making provides greater benefit than treating all or treating none.

    Time frame: Through study completion, up to 7 years

  3. Comparison of AUC between the AI models and clinicians of varying seniority

    The AUC of the AI models will be compared against the diagnostic performance of five physicians with varying levels of clinical experience (ranging from junior resident to senior attending physician) using DeLong test. Statistical significance will be set at p less than 0.05.

    Time frame: Through study completion, up to 7 years

  4. Intraclass Correlation Coefficient (ICC) of automated hip radiographic measurements

    The agreement between automated measurements (CE Angle, Tonnis Angle, Alpha Angle, Femoral Neck-Shaft Angle obtained via CenterNet) and manual measurements performed by two independent radiologists will be evaluated using the Intraclass Correlation Coefficient (ICC). ICC values greater than 0.75 indicate good reliability and greater than 0.90 indicate excellent reliability.

    Time frame: Through study completion, up to 7 years

06

Study locations

1 site
  • The Fourth Medical Center of Chinese PLA General Hospital
    Beijing, Beijing Municipality, China
07

Registry details

Key details

Study ID
NCT07737223
Lead sponsor
ChunBao Li
Collaborators
Beijing Friendship Hospital, The PLA Rocket Force Characteristic Medical Center, Beijing Sport University Hospital, Beijing Normal University Hospital, Deshengmenwai Community Health Service Center, Beijing Longwood Valley MedTech Co., Ltd., The First Medical Center of Chinese PLA General Hospital
Responsible party
ChunBao Li (Deputy Director of Sports Medicine, Chinese PLA General Hospital) — Sponsor-investigator
First posted
Jul 30, 2026
Start date
Jan 1, 2019
Primary completion
Nov 30, 2025
Completion
Dec 30, 2025
Last update
Jul 30, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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