Ultrasonography Assessment of Septic Arthritis on Native Joint (SEPT'ECHO)

March 24, 2016 updated by: Nantes University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Roche-sur-Yon, France, 85000
        • CH La Roche-sur-Yon
      • Nantes, France, 44093
        • CH de Nantes
      • Saint-Nazaire, France, 44600
        • CH Saint-Nazaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Ultrasonography assessment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abnormalities joint structure influencing the septic arthritis evolution and prognosis
Time Frame: 15 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Benoît LE GOFF, Doctor, CHU de Nantes
  • Study Chair: Grégoire CORMIER, Doctor, CHD La Roche sur Yon
  • Principal Investigator: Oriane MEROT, Doctor, CH Saint-Nazaire

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

December 11, 2013

First Submitted That Met QC Criteria

December 17, 2013

First Posted (Estimate)

December 23, 2013

Study Record Updates

Last Update Posted (Estimate)

March 25, 2016

Last Update Submitted That Met QC Criteria

March 24, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC13_0393

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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