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Anterior Cruciate Ligament InjuriesNCT04958915

Application of FMRI in Diagnosis of Anterior Cruciate Ligament Injury

An observational study of Anterior Cruciate Ligament Injuries, run by Peking University Third Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

1. To compare the knee joint MRI 30 ° The flexion position was similar to that of conventional knee joint coil (about 17 °) The advantages and disadvantages in the description and diagnosis of anterior cruciate ligament injury;,2. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Anterior Cruciate Ligament Injuries
What is being tested?
Knee joint 30° flexion scan
How many people
120 participants
Where
1 siteChina
Study dates
1 Mar 2018to 31 Jan 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Outpatients or inpatients who were clinically diagnosed with patellofemoral instability and planned to undergo knee MRI examination from March 2018 to October 2018

Inclusion Criteria: Hospitalized patients who have a clear history of knee joint sports injury who are planning to undergo knee arthroscopy -

Exclusion Criteria: MR examination found to have the following diseases: rheumatoid arthritis, septic arthritis, tumor, joint fibrosis; History of knee surgery.

-

Trial locations and contacts

1 site in 1 country.

China1 site
  • Peking University Third Hospital

    Beijing, Beijing Municipality, 010

Other trials in China

About this study

Official title: Application Value of Flexion Position MRI in Diagnosis of Anterior Cruciate Ligament Injury and Patellofemoral Instability

  1. To compare the knee joint MRI 30 ° The flexion position was similar to that of conventional knee joint coil (about 17 °) The advantages and disadvantages in the description and diagnosis of anterior cruciate ligament injury;,2. To compare the knee joint MRI 30 ° The flexion position was similar to that of conventional knee joint coil (about 17 °) Advantages and disadvantages in description and diagnosis of patellofemoral instability
Read the detailed description

Magnetic resonance imaging is widely used in the imaging diagnosis of knee joint injury. At present, there are two kinds of scanning coils used in our country. One is flexible surface coil, and the patient is 0 ° Scan in the straight position. The other is the special coil for the knee joint. At this time, because the coil itself is hard material and has a certain height, the patient is actually in the knee joint micro bending position (about 17 ° 1) Scan. However, it may not be accurate enough to evaluate ACL injury and patellofemoral instability with knee scan in extension and micro flexion position.,1、 Previous literatures have shown that flexion position is superior to extension position in the description and diagnosis of anterior cruciate ligament injury. The main reasons include: ① in extension position, the femoral attachment is wider and flat, with the increase of flexion angle, the anterior cruciate ligament fiber bundle is twisted, and the femoral segment is narrower in sagittal position, Thus, it can be clearly shown as a cylindrical bundle structure 2; ② The normal ACL was tensioned in the extension position, so the femoral attachment area was not well displayed. With the increase of flexion angle, the femoral segment separated from the intercondylar crest area, and the volume of intercondylar fossa increased; ③ Due to the influence of partial volume artifacts in the extension position, the normal anterior cruciate ligament may also show uneven MRI signal, which is similar to injury, resulting in false positive, while the flexion position can reduce partial volume artifacts. However, there are few studies on the advantages and disadvantages of flexion and micro flexion scanning in the description and diagnosis of anterior cruciate ligament injury at home and abroad.,2、 The medical research of patellofemoral instability found that in the early stage of knee flexion, the patella of normal people began to move to the medial side of the knee while sliding from the starting position to the distal side ° The patella moved inward gradually to the maximum, then turned to the lateral and moved to the knee flexion of 40 ° The patella returned to the median line 4. The patients with patellofemoral instability were 15 °- forty-five ° The center of patella moved from the initial position to the lateral position continuously for 5, so 30 ° The difference between normal people and patients may be more significant.,The purpose of this study is to explore 30 cases ° Application value of flexion position in diagnosis of anterior cruciate ligament injury and patellofemoral instability.

2.Image analysis:Comparison of the diagnosis of anterior cruciate ligament injury between conventional scan position and 30°flexion scan

(1) Two radiologists respectively evaluated the injury of the anterior cruciate ligament.

The evaluation criteria for the full length display status are as follows: 3 points: The anterior cruciate ligament is continuously displayed on multiple levels or the full length is displayed in one level, without obvious artifacts; 2 points: The full length of the anterior cruciate ligament cannot be displayed completely but the section can be displayed, there are artifacts but it does not affect the observation; (1)point: The full length of the anterior cruciate ligament cannot be identified or artifacts affect the observation. The evaluation criteria for the display status of the tearing point and stump are as follows: (3) points: The tear point and stump of the ACL are clearly displayed (2) points: One of the torn points or stumps of the ACL can be clearly displayed, and the other cannot be clearly displayed (1) point: The tear point and stump of the ACL cannot be clearly displayed

Being tested
Knee joint 30° flexion scan
Medical subject headings
Anterior Cruciate Ligament Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Knee joint 30° flexion scanDiagnostic test

    The patient was placed in the supine position, and the knee joint was naturally placed in the knee joint special coil, and the knee joint 30° flexion position scan.

Study groups in NCT04958915
Study groupRoleWhat they receive
30 ° flexion positionScan the knee at 30° flexion
Receives: Diagnostic Test: Knee joint 30° flexion scan
conventional flexion positionRoutine body scan of the knee joint

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Damage diagnosis

    Arthroscopy was used as the gold standard to evaluate the ACCURACY of the two methods in the diagnosis of ligament injury

    Measured: 2019.1.15-2019.1.30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2021
  2. Study start1 Mar 2018
  3. Primary completion13 Oct 2018
  4. Study completion31 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04958915
Sponsor's protocol ID
M2018014
Status last verified
Mar 2018
First submitted
28 Jun 2021
Last updated
12 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Anterior Cruciate Ligament Injuries, run by Peking University Third Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Damage diagnosis (time frame: 2019.1.15-2019.1.30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2021.

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