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Completed

NCT Number: NCT04734093

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ahmed Elsaman

Sohag, Sohag Governorate, 82749, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Evaluation of sonographic signs of gouty arthritis

Diagnostic Test

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.

Primary outcomes

  1. Sonographic signs of gouty arthritis in the knee or 1st MTP joint

    Time frame: at baseline

    Erosions, effusion, echogenic foci, and tophus using OMERACT definitions of sonographic signs of gouty arthritis

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 2, 2021
Registry last updated
May 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.