Assessment Micro-anatomy of the Menisci and Cartilage After Isolated Acute ACL Injury With 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

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

Study Overview

• Status: Terminated
• Conditions: Cartilage Injury; ACL Injury; Meniscus Lesion
• Intervention / Treatment: Device: Ultrahigh Field MRI at 7T

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8008
    • Balgrist University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Isolated Acute Anterior Cruciate Ligament Injury with Ultrahigh Field MRI at 7T	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Balgrist University Hospital
• Investigators: Study Chair: Sandro Fucentese, Prof.Dr.med., Balgrist University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2021
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: January 27, 2022
• First Submitted That Met QC Criteria: June 21, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Leg Injuries; Knee Injuries; Wounds and Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: BASEC-Nr. 2020-02570

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No