NCT04950036

Brief Summary

The purpose of this study is to study the MRI images of acetabular labrum injury by deep learning method, and try to establish a combination model of axial and coronal serial images, and compare with the diagnostic accuracy of radiologists, to establish a deep learning method for accurate identification and classification of acetabular labrum injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,261

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

December 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 29, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2021

Completed
Last Updated

July 2, 2021

Status Verified

June 1, 2021

Enrollment Period

5 months

First QC Date

June 29, 2021

Last Update Submit

June 29, 2021

Conditions

Keywords

artificial intelligenceLabrum injurydignosis

Outcome Measures

Primary Outcomes (1)

  • Research on acetabular labrum injury based on MR: multi-angle deep learning model

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

    2020.12.01-2021.05.30

Study Arms (3)

Normal control group-Grade 0

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

Diagnostic Test: Diagnostic Test

Ligament injury -Grade 1

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

Diagnostic Test: Diagnostic Test

Ligament tear-Grade 2

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

Diagnostic Test: Diagnostic Test

Interventions

Diagnostic TestDIAGNOSTIC_TEST

The results of hip 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
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

From September 2018 to September 2020, MRI was performed in the Department of Radiology, the Third Hospital of Peking University.

You may qualify if:

  • Without any treatment before imaging examination;
  • MR of the hip joint was performed within three 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 hip 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

Interventions

Diagnostic Tests, Routine

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • huishu Yuan, md

    Peking University Third Hospital

    STUDY CHAIR

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 2, 2021

Study Start

December 1, 2020

Primary Completion

April 30, 2021

Study Completion

May 30, 2021

Last Updated

July 2, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations