Clinical trial NCT02018952: Ultrasonography Assessment of Septic Arthritis on Native Joint
Official title: Ultrasonography Assessment of Septic Arthritis on Native Joint: a Descriptive, Exploratory, Prospective, Multicentric Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Arthritis
Keywords: Septic arthritis
Ultrasonography
Prognosis parameters
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2013-12-23
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Abnormalities joint structure influencing the septic arthritis evolution and prognosis
timeFrame: 15 months
Secondary outcomes:
measure: The evolution of the abnormalities joint structure using ultrasonography
timeFrame: 15 months
measure: Return delay apyrexia
timeFrame: 15 months
measure: Delay of surgical management
timeFrame: 15 months
measure: Normalization of C Reactive Protein levels
timeFrame: 15 months
measure: Measure of range of motion at 3 months
timeFrame: 15 months
measure: Percentage of decreased range of motion relative to normal range of motion at 3 months
timeFrame: 15 months
measure: Pain at rest measured by scale at 3 months
timeFrame: 15 months
measure: Pain during activity measured by scale at 3 months
timeFrame: 15 months
measure: Functional outcome score Short Form (SF) 36 at 3 months
timeFrame: 15 months
Other outcomes:
Locations:
city: La Roche-sur-Yon
country: France
facility: CH La Roche-sur-Yon
city: Nantes
country: France
facility: CH de Nantes
city: Saint-Nazaire
country: France
facility: CH Saint-Nazaire
Study officials:
affiliation: Nantes University Hospital
name: Benoît LE GOFF, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: CHD La Roche sur Yon
name: Grégoire CORMIER, Doctor
role: STUDY_CHAIR
affiliation: CH Saint-Nazaire
name: Oriane MEROT, Doctor
role: PRINCIPAL_INVESTIGATOR
References: