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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04118023

Enrollment

112

Registered

2019-10-07

Start date

2019-10-07

Completion date

2022-09-07

Last updated

2025-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthropathy of Knee, Cartilage Damage, Cartilage Injury, Knee Injuries, Knee Pain Swelling

Keywords

7T Magnetic Resonance Imaging, Clinical, Cartilaginous Lesion

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.

Interventions

DIAGNOSTIC_TEST7 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.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026