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NCT Number: NCT06113536

Evaluation of Meniscal Extrusion by Dynamic Ultrasonography in Patients With Ostearthritis

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Meniscus Disorder Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

About this study

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::

  • ultrasound evaluation for assessment of possible meniscal extrusion;
  • At the same time as the ultrasound examination, subjective questionnaires will be administered to patients.Recent radiological examinations of the patients or from the patient's medical record will be collected during or before the diagnostic investigation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 80 years;
  • Signs and symptoms of degenerative pathology of knee cartilage;
  • Patients with Radiographic (X-ray or MRI) signs of OA (K-L grade 0-4); 3.
  • Cooperative patients with pain that does not prevent orthostatism
  • Ability and consent of patients to actively participate in clinical follow-up;
  • Recently performed MRI (maximum 1 month).

Exclusion criteria

  • Patients unable to express consent;
  • Patients undergoing intra-articular infiltration of other substance in the previous 6 months;
  • Patients undergoing knee surgery in the previous 12 months;
  • Patients with malignant neoplasms;
  • Patients with rheumatic diseases;
  • Patients with a history of total/subtotal meniscectomy;
  • Patients with symptomatology such that a dynamic examination in orthostatism is not possible; 7.
  • Patients abusing alcoholic beverages, drugs or medications;
  • Body Mass Index > 40;
  • Pregnant or lactating women;
  • Patients with axis deviation > 5°.

Treatment and study plan

ultrasonographic evaluation

Diagnostic Test

Ultrasonographic evaluation for assessment of possible meniscal extrusion

Primary outcomes

  1. Meniscal extrusion

    Time frame: baseline

    Meniscal extrusion in clinostatism and orthostatism, assessed in millimeters (mm) or percent meniscal extrusion relative to tibial margin, and difference between the two measurements

Secondary outcomes

  1. IKDC-Subjective Score (Subjective International Knee Documentation Committee)

    Time frame: baseline

    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

  2. KOOS Score ( Knee Injury and Osteoarthritis Outcome score)

    Time frame: baseline

    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

  3. VAS-dolore (Visual Analogue Scale)

    Time frame: baseline

    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."

  4. Tegner Activity Level Scale

    Time frame: baseline

    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.

  5. EQ-VAS

    Time frame: baseline

    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."

  6. Objective parameters - Circumferences

    Time frame: baseline

    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

  7. Objective parameters- Range of Motion

    Time frame: baseline

    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.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

Evaluation of Meniscal Extrusion by Dynamic Ultrasonography in Patients With Ostearthritis and Comparison With Magnetic Resonance Imaging Study.

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Nov 2, 2023
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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