Ultrasonography Assessment of Septic Arthritis on Native Joint

Study Overview
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Brief Summary
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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.

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

Conditions
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Septic Arthritis

Intervention / Treatment
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* Other: Ultrasonography assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ultrasonography assessment<br> | Other: Ultrasonography assessment<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Measure of range of motion at 3 months |  | 15 months | 
| Percentage of decreased range of motion relative to normal range of motion at 3 months |  | 15 months | 
| Pain at rest measured by scale at 3 months |  | 15 months | 
| Pain during activity measured by scale at 3 months |  | 15 months | 
| Functional outcome score Short Form (SF) 36 at 3 months |  | 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Septic arthritis, Ultrasonography, Prognosis parameters