An interventional study of Ultrasonographic evaluation in Knee Osteoarthritis and Meniscus Disorder, sponsored by Istituto Ortopedico Rizzoli. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-03-06.
Sponsored by Istituto Ortopedico Rizzoli · Not applicable, Interventional, and Diagnostic
This is a diagnostic, open-label, single-center interventional study. The aim of the study is to evaluate the relationship between medial and lateral meniscus extrusion determined by dynamic ultrasound study and bone edema assessed by MRI study in patients with knee OA.
As a secondary objective, the correlation of the above parameters with the patient's symptomatology assessed by subject clinical questionnaires will be evaluated.
Patients with a diagnosis of knee OA will be included in a study involving evaluation of the correlation between meniscal extrusion assessed by dynamic ultrasonography and bone edema assessed on MRI. A total of 202 patients will be included, who, after providing their signed informed consent to participate in the study, will undergo dynamic ultrasonography. After giving signed consent to participate in the study, the patient will undergo the following examinations::
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 202 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Istituto Ortopedico Rizzoli is the lead sponsor of 298 studies on the registry; 102 are open to participants now.
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Exclusion Criteria:
Ultrasonographic evaluation for assessment of possible meniscal extrusion
Diagnostic Test: Ultrasonographic evaluation
Ultrasonographic evaluation for assessment of possible meniscal extrusion
Meniscal extrusion
Meniscal extrusion in clinostatism and orthostatism, assessed in millimeters (mm) or percent meniscal extrusion relative to tibial margin, and difference between the two measurements
Time frame: baseline
IKDC-Subjective Score (Subjective International Knee Documentation Committee)
The IKDC-Subjective Score (Subjective International Knee Documentation Committee) is a subjective, knee-specific rating scale.The questionnaire examines 3 categories: symptoms, sports activity, and knee function. The response "Unable to perform any of the above activities due to knee pain" receives a score of 0 while the response "Very strenuous activities like jumping or pivoting as in basketball or soccer" receives a score of 4. This is how item 1, which is related to the highest level of activity without significant pain, is scored. For item 2, which asks about the frequency of pain in the last four weeks, the responses "Constant" and "Never" receive scores of 0 and 10, respectively
Time frame: baseline
KOOS Score ( Knee Injury and Osteoarthritis Outcome score)
The full questionnaire consists of five subscales and they cover: pain (9 items), symptoms (7 items of which two relate to stiffness), functions and activities of daily living (17 items) physical function, sports activities and leisure (5 items) and quality of life in relation to the knee (4 items). All items in the relevant subscales have the same response mode, use a 5-point Likert scale, and each question is assigned a score from 0 to 4, where 0 indicates "no difficulty" and 4 "a severe difficulty). Score range 0-100 for each subscale
Time frame: baseline
VAS-dolore (Visual Analogue Scale)
Visual analog scale consisting of a straight line segment (10 cm length), the ends of which correspond to "no pain" and "the strongest pain imaginable."
Time frame: baseline
Tegner Activity Level Scale
The Tegner Activity Level Scale: allows the estimation of a subject's motor activity level with a score between 0 and 10, where 0 represents 'inability' and 10 represents 'participation in competitive sports, such as soccer at the national or international level. This score is the one most commonly used to define the motor activity level of patients with knee disorders.
Time frame: baseline
EQ-VAS
Visual analog scale consisting of a straight line segment (10 cm length), the ends of which correspond to "no pain" and "the strongest pain imaginable."
Time frame: baseline
Objective parameters - Circumferences
Bilateral trans- and supra- patellar circumferences measurement for comparative analysis.The measurement will be taken by the orthopedist by meter and will be reported in centimeters
Time frame: baseline
Objective parameters- Range of Motion
Evaluation of the Range of Motion for comparative analysis. Range of motion (ROM) is a term used to describe how far you can move a joint or muscle in various directions. It is used to measure how much you can move a joint on your own (active ROM) or with the assistance of someone else (passive ROM).Range of motion is measured using a goniometer.
Time frame: baseline
Plan to share: No
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Istituto Ortopedico Rizzoli