NCT04958408

Brief Summary

Knee joint is the most common part of sports injury. MRI is a powerful tool to diagnose knee joint injury. However, it takes a long time to read the film, needs a lot, and some hidden injuries have a high rate of missed diagnosis. The emerging deep learning technology can establish automatic recognition model through large samples. A large sample of knee joint MRI was collected retrospectively to train the deep learning model of knee joint MRI, and the sensitivity and specificity of the deep learning model were verified in multi center. Depending on the clinical needs, the deep learning model annotation system is established. A large number of knee MRI were obtained and labeled. According to the knee joint MRI training depth learning model, and iterative optimization, the final version is formed. Multi center validation was carried out. Continuous operation records and corresponding preoperative knee MRI were obtained from multiple hospitals. The sensitivity and specificity of the model were calculated with operation records as the gold standard. At the same time, an expert team composed of senior radiologists and sports medicine doctors was organized to read the films. The sensitivity and specificity of manual reading and AI reading were compared to prove the superiority of AI reading. This study can improve the efficiency of clinical MRI film reading, reduce the workload of doctors, improve the film reading level of grass-roots hospitals, promote the development of the discipline, and has good social benefits and market prospects.

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
50,000

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 27, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
Last Updated

July 12, 2021

Status Verified

June 1, 2021

Enrollment Period

12 months

First QC Date

June 27, 2021

Last Update Submit

July 8, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Marking system design based on Magnetic Resonance Imaging(MRI)

    According to the development goals, combined with the performance of MRI and the structure of the model algorithm, the labeling rules and logic of knee MRI are determined. On this basis, a labeling system is designed, and different labeling tools are designed for a variety of lesions.

    2021

  • Data export and annotation

    Encrypt the MRI file and import it into the medical standard intelligent labeling system. Create a dedicated tagging account for each tagger to tag. Based on the previously marked image data, develop algorithms for segmenting different lesion areas.

    2021

  • Build a deep learning model

    According to the diagnostic logic, we select the coronal and sagittal images of the knee joint T2 MRI sequence for analysis. And choose the Resnext model that has been verified by a large number of ImageNet and other large data sets to extract the features of the coronal out-of-state images. After the multi-layer convolution operation, the key feature representation of the image is extracted. At the same time, in the process of feature extraction, the batch normalization module is used to perform feature transformation to highlight the most meaningful part of the feature.

    2021

Eligibility Criteria

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

All patients related to sports injuries

You may qualify if:

  • ACL-injured patients;
  • Follow-up of patients after ACL injury;
  • patients with genetic predisposition to ACL injury;

You may not qualify if:

  • Patients with joint injury caused by clear external forces;
  • Definitely have stroke, heart disease, epilepsy, cranial neurosurgery, migraine;
  • Have had a concussion or head injury in the past 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sports Medicine, Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Lin Lin

    Peking University Third Hospital

    STUDY DIRECTOR

Central Study Contacts

Lin Lin

CONTACT

Study Design

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

Study Record Dates

First Submitted

June 27, 2021

First Posted

July 12, 2021

Study Start

January 1, 2021

Primary Completion

December 31, 2021

Study Completion

May 15, 2022

Last Updated

July 12, 2021

Record last verified: 2021-06

Locations