Clinical trial NCT06113536: Evaluation of Meniscal Extrusion by Dynamic Ultrasonography in Patients With Ostearthritis
Official title: Evaluation of Meniscal Extrusion by Dynamic Ultrasonography in Patients With Ostearthritis and Comparison With Magnetic Resonance Imaging Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Meniscus Disorder
Keywords: dynamic ultrasonography
Nuclear magnetic resonance imaging
Meniscal extrusion
Osteoarthritis
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a diagnostic, open-label, single-center interventional study.
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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°.

Primary outcomes:
measure: Meniscal extrusion
timeFrame: baseline
Secondary outcomes:
measure: IKDC-Subjective Score (Subjective International Knee Documentation Committee)
timeFrame: baseline
measure: KOOS Score ( Knee Injury and Osteoarthritis Outcome score)
timeFrame: baseline
measure: VAS-dolore (Visual Analogue Scale)
timeFrame: baseline
measure: Tegner Activity Level Scale
timeFrame: baseline
measure: EQ-VAS
timeFrame: baseline
measure: Objective parameters - Circumferences
timeFrame: baseline
measure: Objective parameters- Range of Motion
timeFrame: baseline
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
affiliation: Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica
name: Luca Andriolo, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
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.
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.