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

NCT03979937 | Completed

• 1 other identifier: CHM-2019/S7/03
• Study Type: observational
• Target: 328
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Joint Effusion; Septic Arthritis; Arthritis

Outcome Measures

Primary Outcomes (1)

• Presence of a septic arthritis

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

  10 days after the arthrocentesis.

Interventions

Arthrocentesis PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier le Mans: lead

Study Sites (1)

Centre Hospitalier Le Mans

Le Mans, 72 000, France

Location

MeSH Terms

Conditions

Hydrarthrosis; Arthritis, Infectious; Arthritis

Interventions

Arthrocentesis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Infections

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Emmanuelle Dernis, MD

  Centre Hospitalier du Mans, Rheumatology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 10, 2019
• Study Start: February 15, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: March 9, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)