NCT04957043

Brief Summary

3 d scan sequence can realize continuous thin layer scanning, the thinnest layer thickness of 0.5 mm, to reduce the effects of partial volume effect and improve the spatial resolution image, the other 3 d sequence can according to need to multiplanar reconstruction based on the original image, the image of the watch is no longer limited to a fixed plane, and can avoid repeated scanning, reducing overall inspection time. Initially, 3D MRI uses gradient echo sequences (3D-GRE). Although the scan time of 3D-GRE is acceptable and has a high spatial resolution, the contrast between tissues is poor. In recent years, is voxel 3D fast spin-echo sequence (3D-FSE) has become an alternative 3D scanning sequence. Compared with the 3D-GRE sequence, 3D-FSE has better-intertissued contrast. However, there are still some problems in the application of 3D sequence in clinical practice. On the one hand, although 3D sequence reduces the overall scanning time, it increases the single scanning time, so it is easy to produce motion artifacts. On the other hand, although many studies have demonstrated the diagnostic efficacy of 3D sequences in the diagnosis of common intraarticular structural injuries, especially in the diagnosis of knee cartilage injuries, the diagnostic value of 3D sequences is comparable to that of conventional 2D-FSE sequences, but the evidence on whether 3D sequences can replace 2D sequences is still insufficient. Recently, a new fast signal acquisition technology -- Compressed Sensing (Compressed Sensing) technology has been gradually applied to many kinds of MRI sequences, and its application in 3D sequences can greatly shorten the single scan time. In this study, Modulated Flip Angle Technique in Refocused Imaging with Extended Echo was applied by United Imaging Co., Ltd. (Compressed Sensing) Train, 3D-Matrix), which is a fast self-selected echo sequence based on variable turn Angle technology, and its single scan time can be shortened to 5 minutes. 3 d sequence to more systematic evaluation on sports injury of knee joint application value, the investigators will study from within the bony structure of knee joint injury, joint structure damage and injury of the surrounding support structure aspects to discuss the diagnosis effect, and with arthroscopy for the gold standard to evaluate the accuracy of the 3 d structure within the sequence in the diagnosis of knee joint injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

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

March 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
Last Updated

July 12, 2021

Status Verified

June 1, 2021

Enrollment Period

4 months

First QC Date

June 29, 2021

Last Update Submit

July 4, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Evaluate the image quality of knee joint imaging with 3D-Matrix sequence

    Evaluate the image quality of knee joint imaging with 3D-Matrix sequence

    2018-2019

  • Evaluate the image accuracy of knee joint imaging with 3D-Matrix sequence

    Using arthroscopy as the gold standard, the accuracy of 3D-Matrix and conventional 2D-FSE sequences in the diagnosis of anterior cruciate ligament (ACL), meniscus and articular cartilage injuries was compared.

    2018-2019

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

About 150 inpatients planned to undergo MRI examination of knee joint

You may qualify if:

  • Have a clear history of knee injury, clinically suspected knee injury, need MRI examination;
  • Arthroscopy or treatment is planned.

You may not qualify if:

  • Patients with the following diseases: rheumatoid arthritis, septic arthritis, tumor, anterior cruciate ligament mucinous degeneration, and articular fibrosis;
  • Previous history of knee surgery;
  • MRI contraindication: patients with metal in body (pacemaker, prosthetic eye, metal implant), pregnancy or claustrophobia;
  • Arthroscopy was not performed after MRI examination for various reasons;
  • The time interval between MRI examination and arthroscopy was more than 2 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 010, China

Location

Study Officials

  • huishu yuan

    Peking University Third Hospital

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 12, 2021

Study Start

March 1, 2018

Primary Completion

July 1, 2018

Study Completion

June 1, 2019

Last Updated

July 12, 2021

Record last verified: 2021-06

Locations