Traumatic Knee InjuryMR7T-KneeTraumNCT05895656
Exploration of Knee Injuries Using 3 Tesla and 7 Tesla Magnetic Resonance Imaging at the University Hospital of Poitiers
A study testing 7 Tesla MRI in people with Traumatic Knee Injury and Knee, run by Poitiers University Hospital.
Trial summary
The knee is the most stressed and exposed joint in sports practice (70 to 85% of Anterior Cruciate Ligament ruptures occur during sports activities). Although traumatic knee injuries are already described in radiology and 1.5 Tesla and 3 Tesla MRI, there are cases of post-traumatic knee pain with a normal MRI (with a… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Traumatic Knee Injury, Knee
- What is being tested?
- 7 Tesla MRI
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2023to 15 Dec 2025
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥ 18 and < 60 years
- Knee injury less than 2 months old
- Patients who have undergone or will undergo a 3T MRI
- Subject with no contraindication to MRI (metallic splinter, pacemaker, …)
- Free subject, without guardianship or curatorship or subordination
- Patient benefiting from a Social Security plan or benefiting from it through a third through a third party
- Informed consent signed by the patient after clear and fair information on the study
Who cannot join
- Subjects with contraindications to 7T MRI (pregnancy, metallic fragments, pacemakers, copper intrauterine devices, tattoos larger than 5 cm in examination area, stents, coils, ocular metallic foreign bodies (accidental or otherwise), cochlear implants, and generally any electronically implanted medical device; metallic heart valves, previously implanted vascular clips on a cranial aneurysm)
- History of knee surgery.
- Patient without Social Security coverage or coverage through a third party.
- Patient suffering from claustrophobia.
- Individuals benefiting from enhanced protection, namely minors, persons deprived of liberty by a judicial or administrative decision, adults under legal protection, and emergency patients.
- Pregnant or breastfeeding women, women of childbearing age without effective contraception (hormonal/mechanical: oral, injectable, transdermal, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy).
About this study
Official title: Exploration of Knee Injuries Using 3 Tesla and 7 Tesla Magnetic Resonance Imaging at the University Hospital of Poitiers.
The knee is the most stressed and exposed joint in sports practice (70 to 85% of Anterior Cruciate Ligament ruptures occur during sports activities). Although traumatic knee injuries are already described in radiology and 1.5 Tesla and 3 Tesla MRI, there are cases of post-traumatic knee pain with a normal MRI (with a risk of underestimating a traumatic injury that may worsen without appropriate treatment) and cases of "ambiguous" MRI findings (uncertainty between low or high-grade ligament or meniscal injury, presence or absence of meniscal attachments, complete versus partial rupture of the Anterior Cruciate Ligament, associated cartilage lesion versus intact cartilage), which directly impact orthopedic or surgical therapeutic management.
Read the detailed description
Knee pain (or gonalgia) is a very common complaint in the general population, accounting for nearly 6% of visits to general practitioners and experienced by approximately 46% of patients at least once in their lifetime (Jackson et al.).
The knee is one of the largest and most complex joints in the body, comprising three different joints and a multitude of stabilizing and functional structures (ligaments, menisci, bursa, tendons, etc.).
This complex functional anatomy partly explains the multiple etiologies of knee pain, especially post-traumatic. Among these etiologies, ligamentous (particularly anterior cruciate ligament), bony, and meniscal injuries are prominent (Webb et al.).
The passive stability of the knee is ensured by a complex capsuloligamentary system. Two ligament systems are usually distinguished: the central pivot (cruciate ligaments) and the peripheral structures (anterior, anterolateral, collateral, and posterior). In the case of injuries to one or more elements of this system, knee instability can occur and be detrimental to functional prognosis. These injuries should be addressed promptly (Bressy et al.).
Furthermore, these capsuloligamentary injuries are frequently associated with complex meniscal, bony, or musculotendinous lesions (Blin et al., Boutry et al.).
With surgical techniques becoming increasingly precise and minimally invasive, surgeons need accurate preoperative localization of these lesions to plan their surgical approach and operative procedure (Fanelli - book).
These injuries are better understood with 3 Tesla MRI, which is the imaging modality of choice, in addition to standard radiographs, for exploring traumatic knee injuries (Blin et al.). MRI, by visualizing contusion areas, helps understand the mechanism of trauma and predict and confirm capsuloligamentary injuries.
However, in our clinical practice, we observe that a certain percentage of MRI examinations are considered unremarkable despite patients experiencing persistent post-traumatic pain or functional discomfort. This could be related to insufficient imaging resolution in relation to the millimetric nature of the explored lesions.
Considering all this data, it has become pertinent for us to:
- Seek to optimize the diagnostic quality of MRI imaging in these patients, as it directly affects orthopedic management.
- Seek to improve existing MRI lesion classifications and develop new ones.
- Develop new MRI tools (sequences) for exploring traumatic knee injuries.
The expected results are:
- Define the 7 Tesla MRI findings of traumatic knee injuries.
- Assess the inter-observer variability between 3T and 7T for a future study on diagnostic power (preliminary data).
- Conditions
- Traumatic Knee Injury, Knee
- Being tested
- 7 Tesla MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7 Tesla MRIOther
Performing an additional 7 Tesla MRI examination as part of the initial treatment pathway.
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe and quantify post-traumatic injuries of the ligaments (Anterior Cruciate Ligament, Posterior Cruciate Ligament, Lateral Collateral Ligament, Medial Collateral Ligament) using 7T MRI compared to 3T MRI in cases of post-traumatic knee pain.
For the Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL), they will be described and classified as follows: no abnormality, complete rupture, or partial rupture depending on the location (proximal, medial, distal). For the Lateral Collateral Ligament (LCL) and Medial Collateral Ligament (MCL), the ligament classification will be applied (3 grades).
Measured: 27 to 30 months
Secondary outcomes (7)
Describe and quantify post-traumatic meniscal injuries using 7T MRI compared to 3T MRI in cases of post-traumatic knee pain.
For the menisci, the classification of Israkes, Trillat, Arnoczky, and Warren will be applied.
Measured: 27 to 30 months
Describe and quantify post-traumatic musculotendinous injuries using 7T MRI compared to 3T MRI in cases of post-traumatic knee pain.
For musculoskeletal injuries:
- 3 grades will be used: inflammatory, partial rupture, complete rupture.
Measured: 27 to 30 months
Describe and quantify post-traumatic bone injuries using 7T MRI compared to 3T MRI in cases of post-traumatic knee pain.
For bone injuries:
- 3 grades will be used: bone edema, subchondral fissure, fracture.
Measured: 27 to 30 months
Describe and quantify post-traumatic cartilage injuries using 7T MRI compared to 3T MRI in cases of post-traumatic knee pain.
For cartilage injuries, the Outerbridge classification will be applied.
Measured: 27 to 30 months
Evaluate Cohen's Kappa coefficient value to quantify the inter-rater reliability with 3 and 7 Tesla MRI findings
The inter- and intra-observer study will be conducted by reviewing the images by different radiologists. This will allow us to quantify the variability by comparing the assessment criteria.
Measured: 27 to 30 months
Evaluate Cohen's Kappa coefficient value to quantify the intra-rater reliability with 3 and 7 Tesla MRI findings
The inter- and intra-observer study will be conducted by reviewing the images by different radiologists. This will allow us to quantify the variability by comparing the assessment criteria.
Measured: 27 to 30 months
Compare the 7T structural MRI findings of traumatic knee injuries to the structural findings of the surgical reports
For defining the semiotics, the MRI report at 7T will be compared to the surgical report, if applicable. The surgical report will be considered as the reference for the lesions identified by the surgeon (as arthroscopy is the gold standard examination).
Measured: 27 to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start15 Jun 2023 (estimated)
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Why it stopped: Recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Knee InjuryStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895656
- Sponsor's protocol ID
- MR7T-KneeTraumatic
- Acronym
- MR7T-KneeTraum
- Status last verified
- Mar 2024
- First submitted
- 22 May 2023
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Knee Injuries Using 3 Tesla and 7 Tesla Magnetic Resonance Imaging at the University Hospital of Poitiers.
- ClinicalTrials.gov ID
- NCT05895656
- Acronym / sponsor ID
- MR7T-KneeTraum / MR7T-KneeTraumatic
- Conditions
- Traumatic Knee Injury, Knee
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 15 Jun 2023 (estimated)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 8 Jun 2023 (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.
The knee is the most stressed and exposed joint in sports practice (70 to 85% of Anterior Cruciate Ligament ruptures occur during sports activities). Although traumatic knee injuries are already described in radiology and 1.5 Tesla and 3 Tesla MRI, there are cases of post-traumatic knee pain with a normal MRI (with a risk of underestimating a traumatic injury that may worsen without appropriate treatment) and cases of "ambiguous" MRI findings (uncertainty between low or high-grade ligament or meniscal injury, presence or absence of meniscal attachments, complete versus partial rupture of the Anterior Cruciate Ligament, associated cartilage lesion versus intact cartilage), which directly impact orthopedic or surgical therapeutic management.
Detailed description
Knee pain (or gonalgia) is a very common complaint in the general population, accounting for nearly 6% of visits to general practitioners and experienced by approximately 46% of patients at least once in their lifetime (Jackson et al.).
The knee is one of the largest and most complex joints in the body, comprising three different joints and a multitude of stabilizing and functional structures (ligaments, menisci, bursa, tendons, etc.).
This complex functional anatomy partly explains the multiple etiologies of knee pain, especially post-traumatic. Among these etiologies, ligamentous (particularly anterior cruciate ligament), bony, and meniscal injuries are prominent (Webb et al.).
The passive stability of the knee is ensured by a complex capsuloligamentary system. Two ligament systems are usually distinguished: the central pivot (cruciate ligaments) and the peripheral structures (anterior, anterolateral, collateral, and posterior). In the case of injuries to one or more elements of this system, knee instability can occur and be detrimental to functional prognosis. These injuries should be addressed promptly (Bressy et al.).
Furthermore, these capsuloligamentary injuries are frequently associated with complex meniscal, bony, or musculotendinous lesions (Blin et al., Boutry et al.).
With surgical techniques becoming increasingly precise and minimally invasive, surgeons need accurate preoperative localization of these lesions to plan their surgical approach and operative procedure (Fanelli - book).
These injuries are better understood with 3 Tesla MRI, which is the imaging modality of choice, in addition to standard radiographs, for exploring traumatic knee injuries (Blin et al.). MRI, by visualizing contusion areas, helps understand the mechanism of trauma and predict and confirm capsuloligamentary injuries.
However, in our clinical practice, we observe that a certain percentage of MRI examinations are considered unremarkable despite patients experiencing persistent post-traumatic pain or functional discomfort. This could be related to insufficient imaging resolution in relation to the millimetric nature of the explored lesions.
Considering all this data, it has become pertinent for us to:
- Seek to optimize the diagnostic quality of MRI imaging in these patients, as it directly affects orthopedic management.
- Seek to improve existing MRI lesion classifications and develop new ones.
- Develop new MRI tools (sequences) for exploring traumatic knee injuries.
The expected results are:
- Define the 7 Tesla MRI findings of traumatic knee injuries.
- Assess the inter-observer variability between 3T and 7T for a future study on diagnostic power (preliminary data).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age ≥ 18 and < 60 years
- Knee injury less than 2 months old
- Patients who have undergone or will undergo a 3T MRI
- Subject with no contraindication to MRI (metallic splinter, pacemaker, …)
- Free subject, without guardianship or curatorship or subordination
Key exclusion criteria (6 listed)
- Subjects with contraindications to 7T MRI (pregnancy, metallic fragments, pacemakers, copper intrauterine devices, tattoos larger than 5 cm in examination area, stents, coils, ocular metallic foreign bodies (accidental or otherwise), cochlear implants, and generally any electronically implanted medical device; metallic heart valves, previously implanted vascular clips on a cranial aneurysm)
- History of knee surgery.
- Patient without Social Security coverage or coverage through a third party.
- Patient suffering from claustrophobia.
- Individuals benefiting from enhanced protection, namely minors, persons deprived of liberty by a judicial or administrative decision, adults under legal protection, and emergency patients.
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 |
|---|---|---|
| 7 Tesla MRIPerforming an additional 7 Tesla MRI examination as part of the initial treatment pathway. | Other | – |
Primary outcome
Describe and quantify post-traumatic injuries of the ligaments (Anterior Cruciate Ligament, Posterior Cruciate Ligament, Lateral Collateral Ligament, Medial Collateral Ligament) using 7T MRI compared to 3T MRI in cases of post-traumatic knee pain.
Time frame: 27 to 30 months
For the Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL), they will be described and classified as follows: no abnormality, complete rupture, or partial rupture depending on the location (proximal, medial, distal). For the Lateral Collateral Ligament (LCL) and Medial Collateral Ligament (MCL), the ligament classification will be applied (3 grades).
7 secondary outcomes
Describe and quantify post-traumatic meniscal injuries using 7T MRI compared to 3T MRI in cases of post-traumatic knee pain.
Time frame: 27 to 30 months
Describe and quantify post-traumatic musculotendinous injuries using 7T MRI compared to 3T MRI in cases of post-traumatic knee pain.
Time frame: 27 to 30 months
Describe and quantify post-traumatic bone injuries using 7T MRI compared to 3T MRI in cases of post-traumatic knee pain.
Time frame: 27 to 30 months
Describe and quantify post-traumatic cartilage injuries using 7T MRI compared to 3T MRI in cases of post-traumatic knee pain.
Time frame: 27 to 30 months
Evaluate Cohen's Kappa coefficient value to quantify the inter-rater reliability with 3 and 7 Tesla MRI findings
Time frame: 27 to 30 months
Evaluate Cohen's Kappa coefficient value to quantify the intra-rater reliability with 3 and 7 Tesla MRI findings
Time frame: 27 to 30 months
Compare the 7T structural MRI findings of traumatic knee injuries to the structural findings of the surgical reports
Time frame: 27 to 30 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 7 Tesla MRI in people with Traumatic Knee Injury and Knee, run by Poitiers University Hospital.
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 7 inclusion and 6 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: withdrawn, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Describe and quantify post-traumatic injuries of the ligaments (Anterior Cruciate Ligament, Posterior Cruciate Ligament, Lateral Collateral Ligament, Medial Collateral Ligament) using 7T MRI compared to 3T MRI in cases of post-traumatic knee pain. (time frame: 27 to 30 months). 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 25 Mar 2024.