Musculoskeletal Ultrasound of the Ankles in Erysipelas-like Erythema of Familial Mediterranean Fever

NCT03917277 | Unknown

• 1 other identifier: APHP190233
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Erysipelas-like erythema (ELE) and arthritis are common manifestations affecting the ankle in Familial Mediterranean Fever. Musculoskeletal ultrasound examination of the ankle has never been performed during an episode of ELE. We hypothesize that ELE is associated with underlying musculoskeletal pathology. In order to support this hypothesis, ankle musculoskeletal ultrasound will be performed within 24 hours of onset of ELE in 15 patients diagnosed with FMF. Results will be correlated with clinical parameters, serum inflammatory markers, and ankle radiography.

Conditions

Erysipelas

Keywords

Erysipelas-like erythema; Familial Mediterranean Fever; Musculoskeletal ultrasound

Outcome Measures

Primary Outcomes (1)

• Musculoskeletal ultrasound evaluation of the ankle

  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.

  Within 24 hours of the onset of ELE

Secondary Outcomes (3)

• Comparison of sonographic and radiographic findings between both ankles

  Within 24 hours of the onset of ELE

• Sonographic evaluation of soft tissue thickness of the ankle

  Within 24 hours of the onset of ELE

• Correlation of sonographic findings with patients' characteristics

  Within 24 hours of the onset of ELE

Study Arms (1)

Musculoskeletal ultrasound of the ankle

EXPERIMENTAL

see "Intervention description"

Device: Musculoskeletal ultrasound

Interventions

Musculoskeletal ultrasound DEVICE

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: 1. Talocrural joint:synovial fluid (scored 0-3);synovitis with synovial hypertrophy and PD signal (each scored 0-3); bone erosion with distance between cortices and presence/absence of DP signal 2. Tibialis anterior,tibialis posterior, extensor digitorum longus, fibularis brevis,fibularis tertius,and calcaneal tendons: presence/absence of tenosynovitis, thickening, hypoechogenicity, nodularity, fusiform aspect, and DP signal 3. Calcaneal enthesis: presence/absence of thickening,hypoechogenicity,calcification, cortical irregularity,and DP signal 4. Retrocalcaneal and calcaneal bursa: presence/absence of bursitis and DP signal

Musculoskeletal ultrasound of the ankle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Patient followed by the National reference center for autoinflammatory diseases and inflammatory amyloidosis (CeRéMAIA) at Tenon Hospital in Paris
• Patient with a diagnosis of FMF based on Livneh criteria and supported by 2 pathogenic MEFV mutations
• Patient with unilateral ankle ELE for less than 24 hours and whose diagnosis is confirmed a posteriori by its spontaneous resolution in 72 hours
• Patient affiliated or entitled to an affiliation to a social security system
• Provision of informed consent

You may not qualify if:

• Incapacity to answer questions, express him(her)self clearly, or collaborate with the performance of the musculoskeletal ultrasound
• Previous surgery, significant trauma, destructive arthropathy, and any other pathology affecting the musculoskeletal structures of the ankle and thus influencing its sonographic examination
• Previous diagnosis of gout
• Current pregnancy
• Patient deprived of liberty or under legal protection

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de Médecine Interne

Paris, 75020, France

Location

MeSH Terms

Conditions

Erysipelas; Familial Mediterranean Fever

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Sophie GEORGIN-LAVIALLE, MD PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Karine LOUATI, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie GEORGIN-LAVIALLE, MD,PhD

CONTACT

+33 1 56 01 60 77; sophie.georgin-lavialle@aphp.fr

Gilles GRATEAU, MD, PhD

CONTACT

+33 1 56 01 60 77; gilles.grateau@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 17, 2019
• Study Start: May 1, 2019
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

FR (1)