Corticosteroid Therapy for Persistent Synovitis in Acute Septic Arthritis on Native Joint (SYNOVITIS)

May 10, 2023 updated by: University Hospital, Strasbourg, France

Acute septic arthritis is a rare but life-threatening and functionally serious disease. The improvement or disappearance of pain and functional recovery are sometimes difficult to obtain, with in some cases the persistence of synovitis due to a prolonged local inflammatory response, despite early and effective treatment. The consequences are significant for patients with often significant chronic pain, repercussions on autonomy and/or profession. An unfavorable evolution with joint destruction and need for replacement by a prosthesis is not uncommon.

Corticosteroid therapy is widely used in rheumatology in similar tables, for the purpose of drug synovectomy, with good results. The risk of infection remains the main contraindication to its use.

There are very few studies on its use in septic arthritis, either fundamentally or in humans, for which there are no data in adults. However, these have shown results encouraging the investigators not to neglect this therapy.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service de Chirurgie Orthopédique Septique - CHU de Strasbourg - France
        • Contact:
        • Sub-Investigator:
          • Alia BARTHEL, MD
        • Contact:
        • Principal Investigator:
          • Jeannot GAUDIAS, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult patient (≥18 years old) having presented with septic arthritis and treated at the Strasbourg University Hospital between January 1, 2012 and December 31, 2021

Description

Inclusion criteria:

  • Adult patient (≥18 years old)
  • having presented with septic arthritis and treated at the Strasbourg University Hospital between January 1, 2012 and December 31, 2021
  • clinical finding of persistent synovitis, defined by the presence of pain, effusion or joint stiffness despite well-conducted treatment
  • having had a diagnosis of joint infection proven by a positive culture of the joint fluid to a pathogenic germ
  • having had treatment with local or systemic corticosteroids.

Exclusion criteria:

  • Patient who has expressed his opposition to the reuse of his data for scientific research purposes.
  • Absence of corticosteroid treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete regression of the pain in a fast way
Time Frame: 6 months after treatment with corticosteroids
6 months after treatment with corticosteroids

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Jeannot GAUDIAS, MD, Service de Chirurgie Orthopédique Septique - CHU de Strasbourg - France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2022

Primary Completion (Anticipated)

December 13, 2023

Study Completion (Anticipated)

December 13, 2023

Study Registration Dates

First Submitted

June 8, 2022

First Submitted That Met QC Criteria

September 5, 2022

First Posted (Actual)

September 7, 2022

Study Record Updates

Last Update Posted (Actual)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8654

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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