ACL Injuries, Meniscus Disorder, Meniscus Lesion
Conditions
Keywords
dynamic ultrasonography, arthroscopy, MRI, Interventional trial
Brief summary
This is a diagnostic, open-label, single-center interventional study. This study aims to evaluate the diagnostic accuracy of dynamic ultrasonography for meniscal injuries in patients with an indication for arthroscopy, and to compare it with the study in MRI.
Detailed description
Patients admitted for ACL injury and indication for arthroscopy will be included in a study involving the evaluation of the diagnostic accuracy of dynamic ultrasound compared with MRI. A total of 254 patients will be included, who after providing their signed informed consent to participate in the study, will undergo dynamic ultrasound. After giving signed consent to participate in the study, the patient will undergo the ultrasound evaluation for assessment of possible meniscal injury; Radiological examinations in the patient's possession or from the patient's medical record will be collected during or before the diagnostic investigation.
Interventions
DIAGNOSTIC_TESTDynamic Ultrasonography assessment
Ultrasound evaluation that will be compared with an MRI.
Sponsors
Istituto Ortopedico Rizzoli
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Single Group Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Patients with an indication for knee arthroscopy with: 1. Age between 18 and 60 years; 2. Unilateral involvement; 3. Presence of symptomatology such that dynamic ultrasound examination is precluded; 4. Ability and consent of patients to actively participate in the study;
Exclusion criteria
1. Patients unable to express consent; 2. Patients with malignant neoplasms; 3. Patients with rheumatic diseases; 4. Patients with diabetes; 5. Patients with metabolic disorders of the thyroid gland; 6. Patients abusing alcoholic beverages, drugs or medications; 7. Body Mass Index \> 35; 8. Pregnant or lactating women;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic sensitivity of Dynamic Ultrasonography assessment | baseline | Baseline ultrasonography evaluation for assessment of possible meniscal injury. The ultrasound examination will be compared with an MRI using the arthroscopy result as the gold standard. |
| Diagnostic specificity of Dynamic Ultrasonography assessment | baseline | Baseline ultrasonography evaluation for assessment of possible meniscal injury. The ultrasound examination will be compared with an MRI using the arthroscopy result as the gold standard. |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORLuca Andriolo, MD
Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica
Outcome results
None listed