Cartilage InjuryNCT04118023
7T MRI to Evaluate Cartilage Defects in the Knee
An observational study of Cartilage Injury and Knee Injuries, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
The investigators propose to prospectively evaluate the accuracy of a novel 7-Tesla (7T) knee MRI protocol for the detection and grading of cartilage lesions in the knee, which is a significant limitation of current MRI techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cartilage Injury, Knee Injuries, Arthropathy of Knee
- What is being tested?
- 7 Tesla Magnetic Resonance Imaging Test
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2019to 7 Sep 2022
- Phase
- Observational
- 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
Study population: Patients of a single surgeon in an outpatient clinic.
Who may be able to join
- Confirmed Knee Symptomatology
- Scheduled Arthroscopic Treatment of Knee
- Adult (equal or greater than 18 years of age)
Who cannot join
- Active infections
- Less than 18 years of age
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Non-Invasive Diagnosis and Grading of Cartilage Defects in the Knee - Accuracy of Ultra High Field 7-Tesla MRI as Compared With Arthroscopy
The investigators propose to prospectively evaluate the accuracy of a novel 7-Tesla (7T) knee MRI protocol for the detection and grading of cartilage lesions in the knee, which is a significant limitation of current MRI techniques.
Read the detailed description
The investigators hypothesize that 7T MRI will be ~ 80% sensitive for detection of cartilaginous lesions. This will be tested in a prospective multi-reader study of 100 patients who are scheduled to have knee arthroscopy. Patients will have two MRIs of the knee: one standard of care and one experimental 7T MRI. Subjects will visit at one time point prior to scheduled knee arthroscopy, for a session time of ~1-2 hours for a single 7T MRI scan.
- Conditions
- Cartilage Injury, Knee Injuries, Arthropathy of Knee, Cartilage Damage, Knee Pain Swelling
- Being tested
- 7 Tesla Magnetic Resonance Imaging Test
- Keywords
- 7T Magnetic Resonance Imaging, Clinical, Cartilaginous Lesion
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7 Tesla Magnetic Resonance Imaging TestDiagnostic test
MAGNETOM Terra - 7T MRI Scanner by Siemens Healthineers. Each patient enrolled will undergo the study imaging test prior to planned diagnostic knee arthroscopy.
| Study group | Role | What they receive |
|---|---|---|
| 7T MRI Group | Patient group that receives 7 Tesla Magnetic Resonance Imaging Receives: Diagnostic Test: 7 Tesla Magnetic Resonance Imaging Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Whole-Organ Magnetic Resonance Imaging Score (WORMS)
- Modified Whole-Organ Magnetic Resonance Imaging Score (WORMS) of the knee is a validated instrument utilized to grade structural abnormalities found in MRI.
- Only the cartilage sub-score of the full WORMS will be scored in the study. Cartilage will be scored on a range from 0-6 for 6 different regional subdivisions for a minimum score of 0 and maximum score of 36. A lower score is considered a better outcome, with a score of 0 equating to normal thickness and signal of cartilage.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start7 Oct 2019
- Primary completion19 Aug 2021
- Study completion7 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage InjuryStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Medical Solutions
- Responsible party
- Principal investigator, Patrick McCulloch,MD, The Methodist Hospital Research Institute
- Investigators
- Susan Miller, MD, MPH, Study chair, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118023
- Sponsor's protocol ID
- Pro00022554
- Status last verified
- Feb 2025
- First submitted
- 4 Oct 2019
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Non-Invasive Diagnosis and Grading of Cartilage Defects in the Knee - Accuracy of Ultra High Field 7-Tesla MRI as Compared With Arthroscopy
- ClinicalTrials.gov ID
- NCT04118023
- Acronym / sponsor ID
- Pro00022554
- Conditions
- Cartilage Injury, Knee Injuries, Arthropathy of Knee, Cartilage Damage, Knee Pain Swelling
- Keywords
- 7T Magnetic Resonance Imaging, Clinical, Cartilaginous Lesion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Siemens Medical Solutions
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 19 Aug 2021 (actual)
- Study completion
- 7 Sep 2022 (actual)
- First posted
- 7 Oct 2019 (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 investigators propose to prospectively evaluate the accuracy of a novel 7-Tesla (7T) knee MRI protocol for the detection and grading of cartilage lesions in the knee, which is a significant limitation of current MRI techniques.
Detailed description
The investigators hypothesize that 7T MRI will be ~ 80% sensitive for detection of cartilaginous lesions. This will be tested in a prospective multi-reader study of 100 patients who are scheduled to have knee arthroscopy. Patients will have two MRIs of the knee: one standard of care and one experimental 7T MRI. Subjects will visit at one time point prior to scheduled knee arthroscopy, for a session time of ~1-2 hours for a single 7T MRI scan.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 7T MRI Group | – | Diagnostic Test: 7 Tesla Magnetic Resonance Imaging TestPatient group that receives 7 Tesla Magnetic Resonance Imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of a single surgeon in an outpatient clinic.
Key inclusion criteria (3 listed)
- Confirmed Knee Symptomatology
- Scheduled Arthroscopic Treatment of Knee
- Adult (equal or greater than 18 years of age)
Key exclusion criteria (3 listed)
- Active infections
- Less than 18 years of age
- Pregnant
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 Magnetic Resonance Imaging TestMAGNETOM Terra - 7T MRI Scanner by Siemens Healthineers. Each patient enrolled will undergo the study imaging test prior to planned diagnostic knee arthroscopy. | Diagnostic test | 7T MRI Group |
Primary outcome
Modified Whole-Organ Magnetic Resonance Imaging Score (WORMS)
Time frame: baseline
* Modified Whole-Organ Magnetic Resonance Imaging Score (WORMS) of the knee is a validated instrument utilized to grade structural abnormalities found in MRI. * Only the cartilage sub-score of the full WORMS will be scored in the study. Cartilage will be scored on a range from 0-6 for 6 different regional subdivisions for a minimum score of 0 and maximum score of 36. A lower score is considered a better outcome, with a score of 0 equating to normal thickness and signal of cartilage.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
Susan Miller, MD, MPH study chair
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cartilage Injury and Knee Injuries, run by The Methodist Hospital Research Institute at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 7 Feb 2025. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Modified Whole-Organ Magnetic Resonance Imaging Score (WORMS) (time frame: baseline). 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 7 Feb 2025.