Ultrasonography Assessment of Septic Arthritis on Native Joint

Septic Arthritis Clinical Trial

— SEPT'ECHO  

Official title:

Ultrasonography Assessment of Septic Arthritis on Native Joint: a Descriptive, Exploratory, Prospective, Multicentric Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02018952
• Other study ID #: RC13_0393
• Status: Completed
• Phase: N/A
• First received: December 11, 2013
• Last updated: March 24, 2016
• Start date: January 2014
• Est. completion date: July 2015

Study information

• Verified date: March 2016
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: The Commission nationale de l’informatique et des libertés
• Study type: Interventional

Clinical Trial Summary

The aim of this trial is to study the interest of ultrasonography among patients with septic arthritis.

Currently, ultrasonography is useful for detecting small fluid effusions, for examining otherwise inaccessible joints, such as the hip and for helping the joint aspiration.

Accurate assessment of disease activity and joint damage in septic arthritis is important for monitoring treatment efficiency and for prediction of the outcome of the disease.

Nowadays, magnetic resonance imaging (MRI) provides better resolution than radiography or tomography for the detection of joint effusion and for differentiation between bone and soft tissue infectious. The sensibility is reported to be nearly 100% with a specificity of more than 75%.

However, MRI is expensive and not rapidly accessible.

Therefore, ultrasonography, a non invasive, painless, inexpensive, and non radiating exam can be used to assess the presence and extent of inflammation, destruction, and tissue response.

The objective is to describe, using ultrasonography, the abnormalities joint structure influenced the septic arthritis evolution and prognosis.

The investigators hope, at the end of this study, to evaluate ultrasonography interest in septic arthritis and to establish ultrasonography prognosis factors to predict treatment efficiency and functional outcome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Major patients hospitalized in Rheumatology, Infectiology, Orthopedy Department (hospital of Nantes, of La Roche sur Yon and of Saint-Nazaire) with a septic arthritis of shoulder, or elbow, or wrist , or hip, or knee, or ankle on native joint, with positive microbiologic culture joint fluid or positive hemoculture; the diagnosis was based on positive histology or imagery with an inflammatory joint fluid if the microbiologic cultures (hemoculture or joint effusion) were negative.

Exclusion Criteria:

• Presence of material on the targeted joint

• Age < 18 years old

• Patients under guardianship

• Pregnancy

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Infectious
• Septic Arthritis

Intervention

Other:
• Ultrasonography assessment
All patients will be seen at day 0, day 4, day 15 and at 3 months. These visits are usually programmed. Only monitoring ultrasonography, a non invasive exam, and self-administered questionnaires will be made, additional to standard exams for all patients included (no control group). Day 0 : Information of patient and no opposition getting Clinical exam Laboratory tests Radiography of the targeted joint Ultrasonography of the targeted joint and controlateral joint (about 20 minutes) Day 4 : Clinical exam Laboratory tests Ultrasonography of the targeted joint and controlateral joint (about 20 minutes) Day15 : Clinical exam Laboratory tests Ultrasonography of the targeted joint and controlateral joint (about 20 minutes) M3 : Clinical exam Laboratory tests Radiography of the targeted joint Ultrasonography of the targeted joint and controlateral joint (about 20 minutes) Functional outcome

Locations

Country	Name	City	State
France	CH La Roche-sur-Yon	La Roche-sur-Yon
France	CH de Nantes	Nantes
France	CH Saint-Nazaire	Saint-Nazaire

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abnormalities joint structure influencing the septic arthritis evolution and prognosis	Ultrasonography description of : synovium aspect : homogeneous, nodular; maximum thickness synovium; synovium doppler signal (grade 0, 1, 2, 3); presence and aspect of joint effusion : anechoic, hypo/hyperechoic, heterogeneous; presence and aspect of bone erosions : single, minimal/deep, multiple, minimal/ deep; presence of a synovium partitioning; soft tissue aspect : cellulitis, myelitis	15 months	No
Secondary	The evolution of the abnormalities joint structure using ultrasonography	To describe the evolution of ultrasonography parameters during the monitoring and to research a link between those ultrasonography parameters and prognostic indicators : ultrasonography parameters at day 0, Day 4, Day 15, and 3 months.	15 months	No
Secondary	Return delay apyrexia	To describe the evolution of ultrasonography parameters during the monitoring and to research a link between those ultrasonography parameters and prognostic indicators : Return delay apyrexia.	15 months	No
Secondary	Delay of surgical management	To describe the evolution of ultrasonography parameters during the monitoring and to research a link between those ultrasonography parameters and prognostic indicators : Delay of surgical management.	15 months	No
Secondary	Normalization of C Reactive Protein levels	To describe the evolution of ultrasonography parameters during the monitoring and to research a link between those ultrasonography parameters and prognostic indicators : Normalization of C Reactive Protein levels.	15 months	No
Secondary	Measure of range of motion at 3 months		15 months	No
Secondary	Percentage of decreased range of motion relative to normal range of motion at 3 months		15 months	No
Secondary	Pain at rest measured by scale at 3 months		15 months	No
Secondary	Pain during activity measured by scale at 3 months		15 months	No
Secondary	Functional outcome score Short Form (SF) 36 at 3 months		15 months	No