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

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

Study Overview

• Status: Completed
• Conditions: Arthritis; Joint Effusion; Septic Arthritis
• Intervention / Treatment: Procedure: Arthrocentesis

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.

• Study Type: Observational
• Enrollment (Actual): 328

Contacts and Locations

Study Locations

• France
  • Le Mans, France, 72 000
    • Centre Hospitalier Le Mans

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adult patients presenting with at least one clinical joint effusion accessible to arthrocentesis, interesting a native non operated joint, without any general antibiotic therapy in the previous 15 days.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of a septic arthritis	Presence of more than 2000 cells/mL and bacterial growth in the articular fluid.	10 days after the arthrocentesis.

Collaborators and Investigators

• Sponsor: Centre Hospitalier le Mans
• Investigators: Principal Investigator: Emmanuelle Dernis, MD, Centre Hospitalier du Mans, Rheumatology Department

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2020
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: June 6, 2019
• First Submitted That Met QC Criteria: June 6, 2019
• First Posted (Actual): June 10, 2019

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Arthritis, Infectious; Hydrarthrosis
• Other Study ID Numbers: CHM-2019/S7/03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No