7T MRI to Evaluate Cartilage Defects in the Knee
Improving Non-Invasive Diagnosis and Grading of Cartilage Defects in the Knee - Accuracy of Ultra High Field 7-Tesla MRI as Compared With Arthroscopy
1 other identifier
observational
112
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2019
CompletedFirst Posted
Study publicly available on registry
October 7, 2019
CompletedStudy Start
First participant enrolled
October 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 19, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 7, 2022
CompletedFebruary 7, 2025
February 1, 2025
1.9 years
October 4, 2019
February 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
baseline
Study Arms (1)
7T MRI Group
Patient group that receives 7 Tesla Magnetic Resonance Imaging
Interventions
MAGNETOM Terra - 7T MRI Scanner by Siemens Healthineers. Each patient enrolled will undergo the study imaging test prior to planned diagnostic knee arthroscopy.
Eligibility Criteria
Patients of a single surgeon in an outpatient clinic.
You may qualify if:
- Confirmed Knee Symptomatology
- Scheduled Arthroscopic Treatment of Knee
- Adult (equal or greater than 18 years of age)
You may not qualify if:
- Active infections
- Less than 18 years of age
- Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Houston Methodist Hospital
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Susan Miller, MD, MPH
The Methodist Hospital Research Institute
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 4, 2019
First Posted
October 7, 2019
Study Start
October 7, 2019
Primary Completion
August 19, 2021
Study Completion
September 7, 2022
Last Updated
February 7, 2025
Record last verified: 2025-02