Ultrasonography Assessment of Septic Arthritis on Native Joint

NCT02018952 | Completed

• 1 other identifier: RC13_0393
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

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.

Conditions

Septic Arthritis

Keywords

Septic arthritis; Ultrasonography; Prognosis parameters

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• The evolution of the abnormalities joint structure using ultrasonography

  15 months

• Return delay apyrexia

  15 months

• Delay of surgical management

  15 months

• Normalization of C Reactive Protein levels

  15 months

• Measure of range of motion at 3 months

  15 months

Study Arms (1)

Ultrasonography assessment

OTHER

Other: Ultrasonography assessment

Interventions

Ultrasonography assessment OTHER

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

Ultrasonography assessment

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Presence of material on the targeted joint
• Age \< 18 years old
• Patients under guardianship
• Pregnancy

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (3)

CH La Roche-sur-Yon

La Roche-sur-Yon, La Roche-sur-Yon, 85000, France

Location

CH Saint-Nazaire

Saint-Nazaire, Saint-Nazaire, 44600, France

Location

CH de Nantes

Nantes, 44093, France

Location

MeSH Terms

Conditions

Arthritis, Infectious

Condition Hierarchy (Ancestors)

Infections; Arthritis; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Benoît LE GOFF, Doctor

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

• Grégoire CORMIER, Doctor

  CHD La Roche sur Yon

  STUDY CHAIR

• Oriane MEROT, Doctor

  CH Saint-Nazaire

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 11, 2013
• First Posted: December 23, 2013
• Study Start: January 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 25, 2016

Record last verified: 2016-03

Locations

FR (3)