Skip to main content
Clinical Trials/NCT04118023
NCT04118023
Completed
Not Applicable

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 Methodist Hospital Research Institute1 site in 1 country112 target enrollmentOctober 7, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cartilage Injury
Sponsor
The Methodist Hospital Research Institute
Enrollment
112
Locations
1
Primary Endpoint
Modified Whole-Organ Magnetic Resonance Imaging Score (WORMS)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 7, 2019
End Date
September 7, 2022
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Patrick McCulloch,MD

Principal Investigator

The Methodist Hospital Research Institute

Eligibility Criteria

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

Outcomes

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.

Study Sites (1)

Loading locations...

Similar Trials