Clinical Trial: Ultrasonography Assessment of Septic Arthritis on Native Joint

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: Nantes University Hospital

Current Primary Outcome: 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


Original Primary Outcome: Abnormalities joint structure influencing the mono 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


Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Nantes University Hospital

Dates:
Date Received: December 11, 2013
Date Started: January 2014
Date Completion:
Last Updated: March 24, 2016
Last Verified: March 2016