Sonographic Signs of Gouty Arthritis in Diagnosed and Suspected Patients Clinical Trial
Official title:
Sonographic Signs of Gouty Arthritis in a Cohort of Egyptian Patients: a Cross Sectional Multicenter Study
| NCT number | NCT04734093 |
| Other study ID # | 21130 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 15, 2020 |
| Est. completion date | April 16, 2021 |
| Verified date | May 2021 |
| Source | Sohag University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 300 |
| Est. completion date | April 16, 2021 |
| Est. primary completion date | April 16, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Ahmed Elsaman | Sohag | ????? |
| Lead Sponsor | Collaborator |
|---|---|
| Sohag University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |