Evaluation of Meniscal Extrusion by Dynamic Ultrasonography in Patients With Ostearthritis

NCT ID: NCT06113536

Last Updated: 2025-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-23

Study Completion Date

2025-01-21

Brief Summary

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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

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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.

Conditions

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Knee Osteoarthritis Meniscus Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a diagnostic, open-label, single-center interventional study.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Ultrasonographic evaluation

Ultrasonographic evaluation for assessment of possible meniscal extrusion

Group Type EXPERIMENTAL

Ultrasonographic evaluation

Intervention Type DIAGNOSTIC_TEST

Ultrasonographic evaluation for assessment of possible meniscal extrusion

Interventions

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Ultrasonographic evaluation

Ultrasonographic evaluation for assessment of possible meniscal extrusion

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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°.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luca Andriolo, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica

Locations

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Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 22392533 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19248082 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26926836 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30828848 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12965941 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20181669 (View on PubMed)

Other Identifiers

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US-MEN

Identifier Type: -

Identifier Source: org_study_id

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