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

NCT ID: NCT03979937

Last Updated: 2022-03-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 328 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-15
• Study Completion Date: 2022-03-01

Brief Summary

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

Detailed Description

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.

Conditions

Joint Effusion; Septic Arthritis; Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Arthrocentesis

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

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier le Mans

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emmanuelle Dernis, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier du Mans, Rheumatology Department

Locations

Centre Hospitalier Le Mans

Le Mans, , France

Countries

France

Other Identifiers

CHM-2019/S7/03

Identifier Type: -

Identifier Source: org_study_id