7T MRI to Evaluate Cartilage Defects in the Knee

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.

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Key information

Conditions

Cartilage Injury Arthropathy of Knee Cartilage Damage Knee Injuries Knee Pain Swelling Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Houston Methodist Hospital

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Confirmed Knee Symptomatology
Scheduled Arthroscopic Treatment of Knee
Adult (equal or greater than 18 years of age)

Exclusion criteria

Active infections
Less than 18 years of age
Pregnant

Treatment and study plan

7 Tesla Magnetic Resonance Imaging Test

Diagnostic Test

MAGNETOM Terra - 7T MRI Scanner by Siemens Healthineers. Each patient enrolled will undergo the study imaging test prior to planned diagnostic knee arthroscopy.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Collaborators

Siemens Medical Solutions

Registry information

Official study 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

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2022
First posted: Oct 7, 2019
Registry last updated: Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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