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

Primary Purpose

Meniscus Lesion, Cartilage Injury, ACL Injury

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Ultrahigh Field MRI at 7T
Sponsored by
Balgrist University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Meniscus Lesion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Balgrist University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

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

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 27, 2022
Last Updated
August 14, 2023
Sponsor
Balgrist University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05433012
Brief Title
Assessment Micro-anatomy of the Menisci and Cartilage After Isolated Acute ACL Injury With MRI at 7T
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2021 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Balgrist University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniscus Lesion, Cartilage Injury, ACL Injury

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Isolated Acute Anterior Cruciate Ligament Injury with Ultrahigh Field MRI at 7T
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Ultrahigh Field MRI at 7T
Intervention Description
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
Primary Outcome Measure Information:
Title
Frequency of occoult meniscus lesions detected in UHF-MRI
Description
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.
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Zimmermann, Dr. med.
Phone
+41443861111
Email
stefan.zimmermann@balgrist.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandro Fucentese, Prof.Dr.med.
Organizational Affiliation
Balgrist University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Balgrist University Hospital
City
Zurich
ZIP/Postal Code
8008
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Zimmermann, Dr. med.
Phone
+41443861111
Email
stefan.zimmermann@balgrist.ch

12. IPD Sharing Statement

Learn more about this trial

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

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