NCT04953026

Brief Summary

This study intends to study the shoulder SLAP injury through deep learning technology and establish a deep learning model through the combination of axial and oblique coronal images to establish a deep learning method that can accurately identify and grade shoulder SLAP injury.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 29, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

July 7, 2021

Status Verified

June 1, 2021

Enrollment Period

8 months

First QC Date

June 29, 2021

Last Update Submit

June 29, 2021

Conditions

Keywords

artificial intelligenceSLAPdiagnosis

Outcome Measures

Primary Outcomes (1)

  • SLAP Injury of the Shoulder Joint: Application Value of Deep Learning in Diagnosis

    The model of deep learning was obtained for diagnosis and grading of SLAP injury and compared with the radiologists of different stages.

    2021.10.1-2022.7.1

Study Arms (3)

Normal control group-Grade 0

Arthroscopic examination of the labrum was normal, and the labrum was intact without injury or tear.

Diagnostic Test: Diagnositic test

Ligament injury -Grade 1

Arthroscopic examination of the shoulder showed labrum degeneration or injury, but no local or complete tear.

Diagnostic Test: Diagnositic test

Ligament tear-Grade 2

Arthroscopy of the shoulder revealed partial or complete loss of labrum.

Diagnostic Test: Diagnositic test

Interventions

Diagnositic testDIAGNOSTIC_TEST

The results of shoulder arthroscopy were taken as the gold standard, and MRI examination was taken as the research object.

Ligament injury -Grade 1Ligament tear-Grade 2Normal control group-Grade 0

Eligibility Criteria

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

Collect and analyze patients who underwent shoulder MR examinations in the Department of Radiology, Peking University Third Hospital from September 2018 to September 2020.

You may qualify if:

  • Without any treatment before imaging examination;
  • MR of the shoulder joint was performed within 3 months before the operation and the image quality was good;
  • Arthroscopic operation was performed in our hospital, and the operation records were complete.

You may not qualify if:

  • History of shoulder surgery, tumor, or previous fracture;
  • Unclear image, serious artifact, or incomplete clinical data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 010, China

Location

MeSH Terms

Conditions

Shoulder InjuriesDisease

Condition Hierarchy (Ancestors)

Wounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 7, 2021

Study Start

October 1, 2021

Primary Completion

June 1, 2022

Study Completion

July 1, 2022

Last Updated

July 7, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations