Suspected knee injuries Suspected knee injuries
Conditions
Interventions
NextMRI scanner (prototype #3 PhysioMRI Tech S.L.)
Sponsors
Bergman Clinics
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with suspected knee injuries (for instance, ligament tears, cartilage damage, tendon injuries, posttraumatic injuries).Patients aged between 18-80.Patients must be able to read, speak, and understand the Dutch language.
Exclusion criteria
Exclusion criteria: Patients who are clninically unstable (with significant changes in medication or condition in the past months (excluding the condition under study, such as knee injuries)).Patients who are not able to safely undergo an MRI scan (e.g. metal implants, cardiac pacemakers, or other contra-indicators (see www.mrisafety.com)). the decision on contra-indicators will be made according to the guidelines outlined in the MRI safety questionnaire document of Bergman Clinics (standard care)).Patients with severe claustrophobia or tinnitus that would prevent them undergoing MRI scans.Patients who are pregnant or who have the possibility of being pregnant, as reported by the patient self.Patients must be able to provide informed consent and comply with the study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is the sensitivity of the NextMRI scanner in detecting/ imaging suspected knee injuries. The performance of the NextMRI scanner will be compared to the gold standard, a conventional MRI scanner, for validation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Image artifacts graded using a Visual Grading Sacle (0 to 4 scale).Specific Absorption rate (SAR).Patient (dis)comfort measured with a patient evaluation questionnaire.Patient satisfaction measured with a patient evaluation questionnaire.Practical usability and user satisfaction measured with a feedback questionnaire for professionals. Number of Adverse Events that are directly related to the NextMRI scanner.Number of Serious Adverse Events that are directly related to the NextMRI scanner. | — |
Countries
Netherlands
Contacts
Public ContactM.J.M. Zee
Bergman Clinics
Outcome results
None listed