7T MRI to Evaluate Cartilage Defects in the Knee

Knee Injuries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04118023
• Other study ID #: Pro00022554
• Status: Completed
• Start date: October 7, 2019
• Est. completion date: September 7, 2022

Study information

• Verified date: March 2023
• Source: The Methodist Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: September 7, 2022
• Est. primary completion date: August 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• 7 Tesla Magnetic Resonance Imaging Test
MAGNETOM Terra - 7T MRI Scanner by Siemens Healthineers. Each patient enrolled will undergo the study imaging test prior to planned diagnostic knee arthroscopy.

Locations

Country	Name	City	State
United States	Houston Methodist Hospital	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The Methodist Hospital Research Institute	Siemens Medical Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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