NCT04955067

Brief Summary

The purpose of this study is to study the injury of the anterior talofibular ligament by deep learning method and compare a variety of different deep learning models to establish a deep learning method that can accurately identify and grade the injury of anterior talofibular ligament, and obtain a model with better recognition and grading effect.

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
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

July 8, 2021

Status Verified

June 1, 2021

Enrollment Period

12 months

First QC Date

June 28, 2021

Last Update Submit

June 29, 2021

Conditions

Keywords

artificial intelligenceanterior talofibular ligamentsports Injury

Outcome Measures

Primary Outcomes (1)

  • Deep Learning of Anterior Talofibular Ligament: Comparison of Different Models

    The model of deep learning was obtained for diagnosis and grading of anterior fibular ligament and compared with the doctors of different grades.

    2021.1-2022.3.1

Study Arms (3)

Normal control group-Grade 0

Arthroscopic examination of the ankle joint was normal, and the ligament was intact without injury or tear.

Diagnostic Test: Diagnositic test

Ligament injury -Grade 1

Arthroscopic examination of the ankle joint showed ligament degeneration or injury, but no local or complete tear.

Diagnostic Test: Diagnositic test

Ligament tear-Grade 2

Arthroscopy of the ankle joint revealed partial or complete loss of ligaments.

Diagnostic Test: Diagnositic test

Interventions

Diagnositic 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, patients underwent ankle MRI examination in the Department of Radiology, the Third Hospital of Peking University.

You may qualify if:

  • Without any treatment before imaging examination;
  • MR of ankle joint was performed within 3 months before 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 ankle surgery, history of cancer or previous fractures.
  • 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

RECRUITING

MeSH Terms

Conditions

Athletic Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • huishu Yuan, MD

    Peking University Third Hospital

    STUDY CHAIR

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 28, 2021

First Posted

July 8, 2021

Study Start

January 1, 2021

Primary Completion

December 30, 2021

Study Completion

March 30, 2022

Last Updated

July 8, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations