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

NCT05433012 | Terminated DMC

• 1 other identifier: BASEC-Nr. 2020-02570
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Meniscus Lesion; Cartilage Injury; ACL Injury

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Isolated Acute Anterior Cruciate Ligament Injury with Ultrahigh Field MRI at 7T

OTHER

Device: Ultrahigh Field MRI at 7T

Interventions

Ultrahigh Field MRI at 7T DEVICE

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

Isolated Acute Anterior Cruciate Ligament Injury with Ultrahigh Field MRI at 7T

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Balgrist University Hospital: lead

Study Sites (1)

Balgrist University Hospital

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Sandro Fucentese, Prof.Dr.med.

  Balgrist University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: June 27, 2022
• Study Start: April 22, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

CH (1)