Evaluation of Meniscal Extrusion by Dynamic Ultrasonography in Patients With Ostearthritis

NCT06113536 | Completed

• 1 other identifier: US-MEN
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Meniscus Disorder

Keywords

dynamic ultrasonography; Nuclear magnetic resonance imaging; Meniscal extrusion; Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• IKDC-Subjective Score (Subjective International Knee Documentation Committee)

  baseline

• KOOS Score ( Knee Injury and Osteoarthritis Outcome score)

  baseline

• VAS-dolore (Visual Analogue Scale)

  baseline

• Tegner Activity Level Scale

  baseline

• EQ-VAS

  baseline

Study Arms (1)

Ultrasonographic evaluation

EXPERIMENTAL

Ultrasonographic evaluation for assessment of possible meniscal extrusion

Diagnostic Test: Ultrasonographic evaluation

Interventions

Ultrasonographic evaluation DIAGNOSTIC_TEST

Ultrasonographic evaluation for assessment of possible meniscal extrusion

Ultrasonographic evaluation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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°.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (6)

• 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.

  PMID: 22392533 BACKGROUND

• 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.

  PMID: 19248082 BACKGROUND

• 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.

  PMID: 26926836 BACKGROUND

• 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.

  PMID: 30828848 BACKGROUND

• 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.

  PMID: 12965941 BACKGROUND

• 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.

  PMID: 20181669 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Luca Andriolo, MD

  Istituto Ortopedico Rizzoli - II Clinica Ortopedica e Traumatologica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a diagnostic, open-label, single-center interventional study.

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 2, 2023
• Study Start: March 23, 2021
• Primary Completion: January 21, 2025
• Study Completion: January 21, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)