Meniscus LesionNCT05433012
Assessment Micro-anatomy of the Menisci and Cartilage After Isolated Acute ACL Injury With MRI at 7T
A study testing Ultrahigh Field MRI at 7T in people with Meniscus Lesion and Cartilage Injury, run by Balgrist University Hospital at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meniscus Lesion, Cartilage Injury, ACL Injury
- What is being tested?
- Ultrahigh Field MRI at 7T
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Apr 2021to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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 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
Read the 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.
- Conditions
- Meniscus Lesion, Cartilage Injury, ACL Injury
- Being tested
- Ultrahigh Field MRI at 7T
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrahigh Field MRI at 7TDevice
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 group | Role | What they receive |
|---|---|---|
| Isolated Acute Anterior Cruciate Ligament Injury with Ultrahigh Field MRI at 7T | Other | Not described Receives: Device: Ultrahigh Field MRI at 7T |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start22 Apr 2021
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Why it stopped: Difficult Recruiting. Too few patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandro Fucentese, Prof.Dr.med., Study chair, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433012
- Sponsor's protocol ID
- BASEC-Nr. 2020-02570
- Status last verified
- Jan 2024
- First submitted
- 27 Jan 2022
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05433012
- Acronym / sponsor ID
- BASEC-Nr. 2020-02570
- Conditions
- Meniscus Lesion, Cartilage Injury, ACL Injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficult Recruiting. Too few patients.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Isolated Acute Anterior Cruciate Ligament Injury with Ultrahigh Field MRI at 7T | Other | Device: Ultrahigh Field MRI at 7T |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrahigh Field MRI at 7TAssessment 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 | Device | Isolated Acute Anterior Cruciate Ligament Injury with Ultrahigh Field MRI at 7T |
Primary outcome
Frequency of occoult meniscus lesions detected in UHF-MRI
Time frame: 12 month
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.
Results and safety
The study was stopped early (reason given: Difficult Recruiting. Too few patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
Related trials for Meniscus Lesion
Recruiting
Sterile Allogeneic Spongioflex® Allograft as Partial Meniscal Replacement After Incomplete Meniscal Loss
Meniscus Lesion
Recruiting
Kinesiotaping in Isolated Meniscus Injuries
Meniscus Injury, Kinesio Taping
Not yet recruitingObservational study
Long-term Follow-up of Actifit® Meniscal Scaffold Patients.
Meniscus Lesion, Meniscus Tear
RecruitingObservational study
Surgical Outcome After Displaced Bucket-handle Meniscal Lesions - Repair Versus Partial Meniscectomy
Meniscus Rupture, Meniscus Injury
Recruiting
Effect of Platelet-rich Plasma (PRP) Injection on Knee Osteoarthritis
Platelets-rich Plasma, Osteoarthritis Knees Both
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandro Fucentese, Prof.Dr.med. study chair
Balgrist University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrahigh Field MRI at 7T in people with Meniscus Lesion and Cartilage Injury, run by Balgrist University Hospital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficult Recruiting. Too few patients.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of occoult meniscus lesions detected in UHF-MRI (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.