Exploratory Study of Ultrasound Signs of Native Septic Arthritis of the Knee (USAK)

January 18, 2024 updated by: Poitiers University Hospital

Primary objective: Description of ultrasound abnormalities seen in native septic arthritis of the knee during each visit.

Primary endpoint: Describe the ultrasound abnormalities observed on Day 0, Day 10, 6 weeks, 3 months, 6 months, during native septic arthritis of the knee.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Secondary Objectives:

  1. Search for poor prognostic factors in native septic arthritis of the knee.
  2. To look for an association between initial sonographic factors and the use of joint lavage.
  3. Look for associations between sonographic signs and clinico-radio-biologic factors at each visit (D10, 6 weeks, 3 months and 6 months)

Study Type

Observational

Enrollment (Estimated)

30

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 Locations

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

No

Sampling Method

Probability Sample

Study Population

Patients with native septic arthritis of the knee

Description

Inclusion Criteria:

  • Male or female of legal age
  • Bacteriologically proven native septic arthritis
  • Meets the definition of septic arthritis: Bacteriological documentation of joint puncture fluid-Native articulation
  • Free subject, without guardianship or trusteeship, or subordination
  • Non-opposition of the patient after clear and fair information about the study

Exclusion Criteria:

  • Presence of material in the affected joint
  • Arthritis with Mycobacterium Tuberculosis.
  • Patients benefiting from a reinforced protection, namely: minors, pregnant and/or breast-feeding women, persons deprived of liberty by a judicial or administrative decision, adults under legal protection

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
native septic arthritis of the knee

Describe the ultrasound abnormalities observed at D0, D10 or before surgery, 6 weeks, 3 months, 6 months, during native septic arthritis of the knee:

thickness and vascularity of the synovial membrane, existence and measurement of joint effusion existence of articular partitioning, erosions and adjacent soft tissue involvement (muscle abscess, cellulitis)
Device: ultrasound
Describe the sonographic abnormalities observed at Day 0, Day 10, 6 weeks, 3 months, 6 months, during native septic arthritis of the knee

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
description of the ultrasound abnormalities seen in native septic arthritis of the knee
Time Frame: Day0, Day 10 or before surgery, 6week, 3months, 6months
Describe the ultrasonographic abnormalities seen in native septic arthritis of the knee
Day0, Day 10 or before surgery, 6week, 3months, 6months

Collaborators and Investigators

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

Sponsor

Poitiers University Hospital

Investigators

  • Principal Investigator: GERVAIS Elisabeth, Poitiers University Hospital

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)

October 27, 2021

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

June 16, 2021

First Submitted That Met QC Criteria

July 4, 2021

First Posted (Actual)

July 7, 2021

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A01301-40

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.

Clinical Trials on Knee Arthritis

Clinical Trials on ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe