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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04958915
Other study ID # M2018014
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2018
Est. completion date January 31, 2019

Study information

Verified date March 2018
Source Peking University Third Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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


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


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date January 31, 2019
Est. primary completion date October 13, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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. -

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Knee joint 30° flexion scan
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.

Locations

Country Name City State
China Peking University Third Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Damage diagnosis Arthroscopy was used as the gold standard to evaluate the ACCURACY of the two methods in the diagnosis of ligament injury 2019.1.15-2019.1.30
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