Sonographic Signs of Gouty Arthritis in a Cohort of Egyptian Patients: a Cross Sectional Multicenter Study

The study is a cross sectional observational multicenter study. It is established in collaboration with the Egyptian college of rheumatology study group (ECRsg). It is conditioned that all the study participants had either mono- or oligo-arthritis with effusion of the knee or the first metatarsophalangeal (MTP) joint in patients with a known history of gout or at high risk. Patients with any known chronic arthritis, comprising rheumatoid arthritis, Sjogren's syndrome, systemic lupus erythematosus, scleroderma, neuropathic arthritis, seronegative spondyloarthropathy, will be excluded from the study. None of the participants had a history of intra-articular injection or aspiration in the scanned joints for 3 months prior to the inclusion in the study. The sonographers will be blinded for clinical data and the EULAR scanning protocol for the knee and 1st MTP will be considered [2]. Further, scanning of the double contour sign over the femur condyles anteriorly and posteriorly in sagittal planes will be assessed. All the sonographers in the study had an experience between 5 and 10 years in the field of musculoskeletal ultrasound.

Study Overview

• Status: Completed
• Conditions: Sonographic Signs of Gouty Arthritis in Diagnosed and Suspected Patients
• Intervention / Treatment: Diagnostic test: Evaluation of sonographic signs of gouty arthritis

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Egypt
  • سوهاج
    • Sohag, سوهاج, Egypt, 82749
      • Ahmed Elsaman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will be collected from several university clinics all over Egypt. All are aged 40 or more with a history of definite gouty arthritis or at high risk and they have active arthritis of at least one joint.

Description

Inclusion Criteria:

• mono- or oligo-arthritis with effusion of the knee or the first metatarsophalangeal
• patients with a known history of gout or at high risk

Exclusion Criteria:

• Patients with any known chronic arthritis, comprising rheumatoid arthritis, Sjoegren's syndrome, systemic lupus erythematosus, scleroderma, neuropathic arthritis, seronegative spondyloarthropathy
• History of intra-articular injection in the last 3 months.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sohag university recruited patients	Diagnostic test: Evaluation of sonographic signs of gouty arthritis; the EULAR scanning protocol for the knee and 1st MTP will be considered [2]. Further, scanning of the double contour sign over the femur condyles anteriorly and posteriorly in sagittal planes will be assessed. Examination of erosions, tophus, double contour, effusion, and echogenic foci will be recorded.
Minia university recruited patients	Diagnostic test: Evaluation of sonographic signs of gouty arthritis; the EULAR scanning protocol for the knee and 1st MTP will be considered [2]. Further, scanning of the double contour sign over the femur condyles anteriorly and posteriorly in sagittal planes will be assessed. Examination of erosions, tophus, double contour, effusion, and echogenic foci will be recorded.
Assuit university recruited patients	Diagnostic test: Evaluation of sonographic signs of gouty arthritis; the EULAR scanning protocol for the knee and 1st MTP will be considered [2]. Further, scanning of the double contour sign over the femur condyles anteriorly and posteriorly in sagittal planes will be assessed. Examination of erosions, tophus, double contour, effusion, and echogenic foci will be recorded.
Kasr Elini recruited patients	Diagnostic test: Evaluation of sonographic signs of gouty arthritis; the EULAR scanning protocol for the knee and 1st MTP will be considered [2]. Further, scanning of the double contour sign over the femur condyles anteriorly and posteriorly in sagittal planes will be assessed. Examination of erosions, tophus, double contour, effusion, and echogenic foci will be recorded.
Tanta university recruited patients	Diagnostic test: Evaluation of sonographic signs of gouty arthritis; the EULAR scanning protocol for the knee and 1st MTP will be considered [2]. Further, scanning of the double contour sign over the femur condyles anteriorly and posteriorly in sagittal planes will be assessed. Examination of erosions, tophus, double contour, effusion, and echogenic foci will be recorded.
Monofia university recruited patients	Diagnostic test: Evaluation of sonographic signs of gouty arthritis; the EULAR scanning protocol for the knee and 1st MTP will be considered [2]. Further, scanning of the double contour sign over the femur condyles anteriorly and posteriorly in sagittal planes will be assessed. Examination of erosions, tophus, double contour, effusion, and echogenic foci will be recorded.
Aswan university recruited patients	Diagnostic test: Evaluation of sonographic signs of gouty arthritis; the EULAR scanning protocol for the knee and 1st MTP will be considered [2]. Further, scanning of the double contour sign over the femur condyles anteriorly and posteriorly in sagittal planes will be assessed. Examination of erosions, tophus, double contour, effusion, and echogenic foci will be recorded.
Ain shams university recruited patients	Diagnostic test: Evaluation of sonographic signs of gouty arthritis; the EULAR scanning protocol for the knee and 1st MTP will be considered [2]. Further, scanning of the double contour sign over the femur condyles anteriorly and posteriorly in sagittal planes will be assessed. Examination of erosions, tophus, double contour, effusion, and echogenic foci will be recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sonographic signs of gouty arthritis in the knee or 1st MTP joint	Erosions, effusion, echogenic foci, and tophus using OMERACT definitions of sonographic signs of gouty arthritis	at baseline

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2020
• Primary Completion (Actual): April 16, 2021
• Study Completion (Actual): April 16, 2021

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): February 2, 2021

Study Record Updates

• Last Update Posted (Actual): May 4, 2021
• Last Update Submitted That Met QC Criteria: May 2, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout; Arthritis; Arthritis, Gouty
• Other Study ID Numbers: 21130

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No