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NCT Number: NCT02018952

Ultrasonography Assessment of Septic Arthritis on Native Joint

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.

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Key information

Conditions

Septic Arthritis Arthritis Arthritis, Infectious Infections Joint Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH La Roche-sur-Yon, La Roche-sur-Yon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Measure of range of motion at 3 months

    Time frame: 15 months

  6. Percentage of decreased range of motion relative to normal range of motion at 3 months

    Time frame: 15 months

  7. Pain at rest measured by scale at 3 months

    Time frame: 15 months

  8. Pain during activity measured by scale at 3 months

    Time frame: 15 months

  9. Functional outcome score Short Form (SF) 36 at 3 months

    Time frame: 15 months

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: SEPT'ECHO

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 23, 2013
Registry last updated
Mar 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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