7T MRI to Evaluate Cartilage Defects in the Knee

Completed

• Conditions: Knee Pain Swelling; Knee Injuries; Arthropathy of Knee; Cartilage Damage; Cartilage Injury
• Interventions: Diagnostic Test: 7 Tesla Magnetic Resonance Imaging Test

• Registration Number: NCT04118023
• Lead Sponsor: The Methodist Hospital Research Institute

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.

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 Timeline

• Study First Submitted: 2019-10-04
• Study First Submitted QC: 2019-10-04
• Study Start: 2019-10-07
• Study First Posted: 2019-10-07
• Primary Completion: 2021-08-19
• Study Completion: 2022-09-07
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
7T MRI Group	7 Tesla Magnetic Resonance Imaging Test	Patient group that receives 7 Tesla Magnetic Resonance Imaging

Primary Outcome Measures

Name	Time	Method
Modified Whole-Organ Magnetic Resonance Imaging Score (WORMS)	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.

Trial Locations

Locations (1)

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States