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

ACL Injury Clinical Trial

Official title:

Assessment of the Micro-anatomy of the Menisci and Cartilage in Patients With Presumed Isolated Acute Anterior Cruciate Ligament Injury With Ultrahigh Field MRI at 7T

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05433012
• Other study ID #: BASEC-Nr. 2020-02570
• Status: Terminated
• Phase: N/A
• Start date: April 22, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: January 2024
• Source: Balgrist University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

However, there is no evidence that ACL reconstruction can 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 of secondary knee osteoarthritis. Therefore, the treatment strategy for ACL injuries is strongly influenced by the presence of concomitant meniscal injuries on initial magnetic resonance imaging (MRI).

To achieve higher spatial resolution and faster image acquisition, there is a clear trend toward higher field strength MRI.

Meniscal injuries repeatedly occur during the course after isolated ACL ruptures, and the question is whether these injuries occurred during the original trauma or as a result of the torn ACL.

Therefore, the primary objective of the current study was to evaluate the potential utility of ultrahigh-field MRI (T7) in detecting occult meniscal tears or cartilage injuries 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. Subsequently, different orthopedic surgeons and radiologists will evaluate the images.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ACL Injury
• Anterior Cruciate Ligament Injuries
• Cartilage Injury
• Meniscus Lesion
• Wounds and Injuries

Intervention

Device:
• Ultrahigh Field MRI at 7T
Assessment of the micro-anatomy of the menisci and cartilage in patients with presumed Isolated Acute Anterior Cruciate Ligament Injury with Ultrahigh Field MRI at 7T

Locations

Country	Name	City	State
Switzerland	Balgrist University Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of occoult meniscus lesions detected in UHF-MRI	The Menisci are assessed at 6 possible locations in the knee and Meniscal alterations at different locations in the same patient cannot necessarily be considered as independent observations. Therefore, a summary analysis over all 6 possible locations will be conducted to avoid unnecessary multiple testing in separate analyses.	12 month