Musculoskeletal Ultrasound of the Ankles in Erysipelas-like Erythema of Familial Mediterranean Fever (ECHOPERY)
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|ClinicalTrials.gov Identifier: NCT03917277|
Recruitment Status : Not yet recruiting
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Erysipelas||Device: Musculoskeletal ultrasound||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Musculoskeletal Ultrasound of the Ankles in Erysipelas-like Erythema of Familial Mediterranean Fever|
|Estimated Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||November 30, 2019|
|Estimated Study Completion Date :||November 30, 2019|
Experimental: Musculoskeletal ultrasound of the ankle
see "Intervention description"
Device: Musculoskeletal ultrasound
Ankle sonographic examination will be performed using Samsung UGEO H60 ultrasound machine in use since 2016. In order to optimize reproducibility, all examinations will be performed by a single examiner. Multiplanar (longitudinal/transverse) scanning will be done in B- and PD-mode to identify pathologies defined by the OMERACT network in the following structures:
- Musculoskeletal ultrasound evaluation of the ankle [ Time Frame: Within 24 hours of the onset of ELE ]Presence of one or more of the following musculoskeletal pathologies identified by sonographic examination of the ankle: synovial fluid, synovitis, and/or bone erosions in the talocrural joint; tendinous anomalies in the tibialis anterior, tibialis posterior, extensor digitorum longus, fibularis brevis, fibularis tertius, and calcaneal tendons; calcaneal enthesopathy, and retrocalcaneal and calcaneal bursitis.
- Comparison of sonographic and radiographic findings between both ankles [ Time Frame: Within 24 hours of the onset of ELE ]Compare findings on musculoskeletal ultrasound and radiography between the ankle ipsilateral and contralateral to ELE.
- Sonographic evaluation of soft tissue thickness of the ankle [ Time Frame: Within 24 hours of the onset of ELE ]Measure and compare soft tissue thickness between the ankle ipsilateral and contralateral to ELE
- Correlation of sonographic findings with patients' characteristics [ Time Frame: Within 24 hours of the onset of ELE ]Correlate presence of musculoskeletal ultrasound pathologies of the ankle ipsilateral to ELE with clinical and paraclinical parameters.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917277
|Contact: Sophie GEORGIN-LAVIALLE, MD,PhD||+33 1 56 01 60 firstname.lastname@example.org|
|Contact: Gilles GRATEAU, MD, PhD||+33 1 56 01 60 email@example.com|
|Principal Investigator:||Sophie GEORGIN-LAVIALLE, MD PhD||Assistance Publique - Hôpitaux de Paris|
|Principal Investigator:||Karine LOUATI, MD||Assistance Publique - Hôpitaux de Paris|