NCT05635006

Brief Summary

Spinal facet joint osteoarthritis is a disease with high incidence among people over 40 years old. It is a disease characterized by a series of degenerative pathological changes and clinical features of synovium, articular cartilage, subchondral bone, joint space and accessory tissues of spinal facet joints under the action of multiple factors. Some physiological or pathological factors can lead to osteoarthritis of spinal facet joints. Patients with spinal facet osteoarthritis often have different degrees of clinical manifestations such as back pain and dyskinesia, which significantly affect the physical and mental health of patients. The severity of spinal facet osteoarthritis not only has a certain impact on low back pain and changes in low back muscle density, but also affects patient management and treatment plan. At present, different doctors have certain subjectivity in the grading reading of lumbar facet osteoarthritis, and the consistency and repeatability of the results are poor. Moreover, doctors need to read image images and judge the grading is very time-consuming and repetitive work. In recent years, the application of deep learning technology in medical image analysis has been widely concerned by clinicians. Deep learning has great potential benefits in medical imaging diagnosis. It can provide semi-automatic reports under the supervision of radiologists, so as to improve the accuracy, consistency, objectivity and rapidity of disease degree assessment, and further support clinical decision-making on this basis. This project plans to develop an intelligent diagnosis and classification system for degenerative diseases of small joints of the spine with multi task and in-depth learning, and verify its clinical feasibility, aiming to help clinicians improve the accuracy, consistency, objectivity and rapidity of the corresponding disease degree evaluation, and further support the follow-up clinical decision-making.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,132

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Dec 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Dec 2022Dec 2026

First Submitted

Initial submission to the registry

November 23, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 2, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

December 31, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

4 years

First QC Date

November 23, 2022

Last Update Submit

August 8, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • To compare the accuracy of multitask deep learning model and clinicians in judging spinal facet joint degeneration

    It is mainly used to indicate the number of correctly predicted samples in the total number of samples.True Positive(TP),False Negative(FN), False Positive(FP),True Negative(TN).Accuracy = (TP + TN) / (TP + FN + FP +TN)

    2022.12.01-2023.07.31

  • To compare the precision of multitask deep learning model and clinicians in judging spinal facet joint degeneration

    True Positive(TP),False Negative(FN), False Positive(FP),True Negative(TN).Precision = TP / (TP+FP)

    2022.12.01-2023.07.31

  • To compare the sensitivity of multitask deep learning model and clinicians in assessing spinal facet joint degeneration

    True Positive(TP),False Negative(FN), False Positive(FP),True Negative(TN).Sensitivity=TP / (TP+FN)

    2022.12.01-2023.07.31

  • To compare the specificity of multitask deep learning model and clinicians in assessing spinal facet joint degeneration

    True Positive(TP),False Negative(FN), False Positive(FP),True Negative(TN).Specificity=TN / (TN+FP)

    2022.12.01-2023.07.31

  • Calculate the F1 score for evaluating the severity of facet joints degeneration in the multitask deep learning model

    F1 score is an important evaluation indicator for automatic classification,F1 =2\*Precision\*Sensitivity/(Precision+Sensitivity)=2TP/(2TP+FP+FN)

    2022.12.01-2023.07.31

  • ROC (Receiver Operation Characteristic) is called receiver operation characteristic curve, which is an index to evaluate the performance of deep learning model

    ROC (Receiver Operation Characteristic) is called receiver operation characteristic curve. The closer the curve is to the upper left corner, the better the classifier is. The area under the ROC curve is called AUC. The larger the AUC is, the better the classification effect of the classifier will be.

    2022.12.01-2023.07.31

Study Arms (3)

Training group

70% of the participants were randomly divided into training groups to train the learning performance of the machine

Validation group

15% of the participants were randomly divided into validation groups to enhance the learning performance of the machine and avoid over fitting

Test group

15% of the participants were randomly divided into test groups to test the learning performance of the machine and draw research conclusions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

For patients receiving imaging examination due to low back pain, the degree of degeneration of the facet joints of the patients is no to severe. Remove patients meeting the exclusion criteria to avoid poor image quality affecting judgment.

You may qualify if:

  • \- From 2020 to 2023, data of patients receiving lumbar imaging examination in the Fifth Affiliated Hospital of Sun Yat sen University and other hospital.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The fifth affiliated hospital of SYSU

Zhuhai, Guangdong, China

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

November 23, 2022

First Posted

December 2, 2022

Study Start

December 31, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

August 13, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

If necessary, it can be provided

Locations