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.
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.
About this study
Official title: Application Value of Flexion Position MRI in Diagnosis of Anterior Cruciate Ligament Injury and Patellofemoral Instability
- 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
- Conditions
- Anterior Cruciate Ligament Injuries
- 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 group | Role | What they receive |
|---|---|---|
| 30 ° flexion position | Scan the knee at 30° flexion Receives: Diagnostic Test: Knee joint 30° flexion scan | |
| conventional flexion position | Routine body scan of the knee joint |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted12 Jul 2021
- Study start1 Mar 2018
- Primary completion13 Oct 2018
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huishu Yuan, Study chair, Peking University Third Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application Value of Flexion Position MRI in Diagnosis of Anterior Cruciate Ligament Injury and Patellofemoral Instability
- ClinicalTrials.gov ID
- NCT04958915
- Acronym / sponsor ID
- M2018014
- Conditions
- Anterior Cruciate Ligament Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 13 Oct 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30 ° flexion position | – | Diagnostic Test: Knee joint 30° flexion scanScan the knee at 30° flexion |
| conventional flexion position | – | –Routine body scan of the knee joint |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Knee joint 30° flexion scanThe 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. | Diagnostic test | 30 ° flexion position |
Primary outcome
Damage diagnosis
Time frame: 2019.1.15-2019.1.30
Arthroscopy was used as the gold standard to evaluate the ACCURACY of the two methods in the diagnosis of ligament injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huishu Yuan study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
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.