Evaluation of Meniscal Extrusion by Dynamic Ultrasonography in Patients With Ostearthritis

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06113536
• Other study ID #: US-MEN
• Status: Recruiting
• Phase: N/A
• Start date: March 23, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: Luca Andriolo, MD
• Phone: 6366567
• Email: luca.andriolo[@]ior.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 202
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age between 18 and 80 years;

2. Signs and symptoms of degenerative pathology of knee cartilage;

3. Patients with Radiographic (X-ray or MRI) signs of OA (K-L grade 0-4); 3.

4. Cooperative patients with pain that does not prevent orthostatism

5. Ability and consent of patients to actively participate in clinical follow-up;

6. Recently performed MRI (maximum 1 month).

Exclusion Criteria:

1. Patients unable to express consent;

2. Patients undergoing intra-articular infiltration of other substance in the previous 6 months;

3. Patients undergoing knee surgery in the previous 12 months;

4. Patients with malignant neoplasms;

5. Patients with rheumatic diseases;

6. Patients with a history of total/subtotal meniscectomy;

7. Patients with symptomatology such that a dynamic examination in orthostatism is not possible; 7.

8. Patients abusing alcoholic beverages, drugs or medications;

9. Body Mass Index > 40;

10. Pregnant or lactating women;

11. Patients with axis deviation > 5°.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Meniscus Disorder
• Osteoarthritis

Intervention

Diagnostic Test:
• Ultrasonographic evaluation
Ultrasonographic evaluation for assessment of possible meniscal extrusion

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (6)

Englund M, Guermazi A, Roemer FW, Aliabadi P, Yang M, Lewis CE, Torner J, Nevitt MC, Sack B, Felson DT. Meniscal tear in knees without surgery and the development of radiographic osteoarthritis among middle-aged and elderly persons: The Multicenter Osteoarthritis Study. Arthritis Rheum. 2009 Mar;60(3):831-9. doi: 10.1002/art.24383. — View Citation

Felson DT, McLaughlin S, Goggins J, LaValley MP, Gale ME, Totterman S, Li W, Hill C, Gale D. Bone marrow edema and its relation to progression of knee osteoarthritis. Ann Intern Med. 2003 Sep 2;139(5 Pt 1):330-6. doi: 10.7326/0003-4819-139-5_part_1-200309020-00008. — View Citation

Loeser RF, Goldring SR, Scanzello CR, Goldring MB. Osteoarthritis: a disease of the joint as an organ. Arthritis Rheum. 2012 Jun;64(6):1697-707. doi: 10.1002/art.34453. Epub 2012 Mar 5. No abstract available. — View Citation

Ozdemir M, Turan A. Correlation Between Medial Meniscal Extrusion Determined by Dynamic Ultrasound and Magnetic Resonance Imaging Findings of Medial-Type Knee Osteoarthritis in Patients With Knee Pain. J Ultrasound Med. 2019 Oct;38(10):2709-2719. doi: 10.1002/jum.14976. Epub 2019 Mar 4. — View Citation

Podlipska J, Guermazi A, Lehenkari P, Niinimaki J, Roemer FW, Arokoski JP, Kaukinen P, Liukkonen E, Lammentausta E, Nieminen MT, Tervonen O, Koski JM, Saarakkala S. Comparison of Diagnostic Performance of Semi-Quantitative Knee Ultrasound and Knee Radiography with MRI: Oulu Knee Osteoarthritis Study. Sci Rep. 2016 Mar 1;6:22365. doi: 10.1038/srep22365. Erratum In: Sci Rep. 2016 Sep 16;6:33109. — View Citation

Wang Y, Wluka AE, Pelletier JP, Martel-Pelletier J, Abram F, Ding C, Cicuttini FM. Meniscal extrusion predicts increases in subchondral bone marrow lesions and bone cysts and expansion of subchondral bone in osteoarthritic knees. Rheumatology (Oxford). 2010 May;49(5):997-1004. doi: 10.1093/rheumatology/keq034. Epub 2010 Feb 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline
Secondary	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	baseline
Secondary	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	baseline
Secondary	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."	baseline
Secondary	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.	baseline
Secondary	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."	baseline
Secondary	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	baseline
Secondary	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.	baseline