Assessment Micro-anatomy of the Menisci and Cartilage After Isolated Acute ACL Injury With MRI at 7T

  • STATUS
    Recruiting
  • End date
    Apr 30, 2023
  • participants needed
    200
  • sponsor
    Balgrist University Hospital
Updated on 15 July 2022
osteoarthritis
torn meniscus
imaging procedures
acl injuries

Summary

There is an ongoing debate regarding the optimal treatment strategy in patients suffering from an acute ACL rupture. Some authors suggest that a non-operative treatment with neuromusculoskeletal rehabilitation program provides sufficient stability and effective recovery after acute injury to the ACL. Others advocate early ACL reconstruction as a first-line treatment for almost all of these patients to reduce the risk of joint instability, thereby preventing secondary joint damage such as meniscal injuries and osteoarthritis. Nevertheless, there is no evidence that an ACL reconstruction might actually prevent the development of knee osteoarthritis. However, concomitant meniscal injuries, either at the time of the ACL injury or secondary to the ACL injury, significantly increase the risk for secondary knee osteoarthritis. Therefore, the treatment strategy of ACL injuries is strongly influenced by the presence of concomitant meniscal injuries on initial magnetic resonance imaging (MRI).

In order to gain higher spatial resolution and faster image acquisition, a clear trend toward higher field strength MRI exists. However, there is still a paucity of data in the current literature, whether these improvements actually benefit patients and treating physicians.

Again and again, meniscal injuries occur in the course after isolated ACL ruptures, where the question arises whether these injuries occurred during the initial trauma or due to the ruptured ACL.

Thus, 200 patients with an acute, presumably isolated ACL rupture who have received a standard MRI will additionally be examined with an ultrahigh-field MRI (T7). Therefore, the primary objective of the current study was to evaluate the potential utility of ultrahigh-field MRI (T7) in detecting occult meniscal tears associated with presumed isolated acute ACL injuries compared with high-field MRI (T3 or less). The secondary objective was to evaluate the influence of meniscal tear location and meniscal tear pattern on the sensitivity of high-field MRI compared with ultrahigh-field MRI in detecting meniscal tears.

Description

Study population The investigator set the sample size to 200 patients.

Primary outcome

  • Diagnostic accuracy of ultrahigh field MRI (T7) compared to high field MRI (T3 or less) for detection of meniscal injuries associated with acute ACL injury Secondary outcome
  • Influence of 1) Location of injury and 2) meniscal tear pattern (modified WORMS18,19) on the sensitivity of high field MRI compared to ultrahigh field MRI for detection of meniscal tears

Details
Condition Meniscus Lesion, Cartilage Injury, ACL Injury
Treatment Ultrahigh Field MRI at 7T
Clinical Study IdentifierNCT05433012
SponsorBalgrist University Hospital
Last Modified on15 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Presumed isolated, acute rupture of the anterior cruciate ligament (trauma not older than 4 weeks) diagnosed by high-field MRI (3 Tesla or less) at Balgrist
Written informed consent of the study participant
Age 18 years or older

Exclusion Criteria

Previous knee surgery or trauma
Presence of concomitant meniscal injury on high-field MRI (3 Tesla or less)
Advanced gonarthrosis (Kellgren-Lawrence score greater than 2)
Contraindication to the performance of MRI
Unsigned informed consent
Inability to follow study procedures (e.g., due to cognitive impairment) or inadequate knowledge of project language
Pregnancy
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note