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

Sponsor
Sohag University (Other)
Overall Status
Completed
CT.gov ID
NCT04734093
Collaborator
(none)
300
1
5
60.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Evaluation of sonographic signs of gouty arthritis

Study Design

Study Type:
Observational
Actual Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Sonographic Signs of Gouty Arthritis in a Cohort of Egyptian Patients: a Cross Sectional Multicenter Study
Actual Study Start Date :
Nov 15, 2020
Actual Primary Completion Date :
Apr 16, 2021
Actual Study Completion Date :
Apr 16, 2021

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Sonographic signs of gouty arthritis in the knee or 1st MTP joint [at baseline]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ahmed Elsaman Sohag سوهاج Egypt 82749

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Mahrous, Associate professor, Sohag University
ClinicalTrials.gov Identifier:
NCT04734093
Other Study ID Numbers:
  • 21130
First Posted:
Feb 2, 2021
Last Update Posted:
May 4, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 4, 2021