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Completed

NCT Number: NCT03979937

Development and Validation of a Simple Diagnostic Tool Predictive of the Aseptic Character of Joint Effusion

Development and validation of a simple diagnostic tool predictive of the aseptic character of joint effusion in the primary care setting.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Le Mans

Le Mans, 72 000, France

About this study

In accordance with guidelines and because of the potential gravity that this situation could represent, any joint effusion must be considered as a septic arthritis until proven otherwise, thus justifying an arthrocentesis and an adequate treatment. Nevertheless, because of epidemiology in primary care, this pragmatic attitude is quite commonly obscured and practices vary according to the experience of the doctor and his personal habits. As a result, the arthrocentesis is not commonly performed and anti-inflammatory treatment, whether based on NSAIDs or corticosteroids, is even sometimes administered to the patient despite the contrary guidelines. Although usually effective, this attitude is however not without risks. In this context, it seems interesting to develop a simple, reproducible and applicable diagnostic tool in a primary care setting for predicting the risk of septic arthritis.

This study is therefore aimed at the development and validation of a predictive score based on simple clinical and paraclinical data (such as the macroscopic appearance of the synovial fluid removed) in a patient with an effusion, whatever either the clinical presentation, whether isolated or integrated in a more complex clinical presentation, whether associated with locoregional inflammatory or general signs or not.

Who can participate

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

Inclusion criteria

  • Adult patient (age ≥ 18 years)
  • Hospitalized in the conventional hospitalization unit or day hospitalization unit or received in consultation within the Rheumatology or Infectious Diseases units at the Le Mans General Hospital
  • presenting at least one joint effusion at clinical examination
  • Interesting a native, nonoperated joint, accessible to a puncture based on clinical markers, determined by palpatory anatomy
  • Affiliated to social security
  • No opposition expressed after written information

Exclusion criteria

  • General antibiotic therapy in progress or completed less than 15 days before
  • Failure to perform the arthrocentesis
  • Person subject to a legal protection measure, not allowing his compliance with the study
  • Participant already included in another study (exclusivity clause)

Treatment and study plan

Arthrocentesis

Procedure

Arthrocentesis to determine the nature of the effusion (septic or aseptic).

Primary outcomes

  1. Presence of a septic arthritis

    Time frame: 10 days after the arthrocentesis.

    Presence of more than 2000 cells/mL and bacterial growth in the articular fluid.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier le Mans

Other

Registry information

Acronym: PRASEPT

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 10, 2019
Registry last updated
Mar 9, 2022

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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