Diagnostic Criteria for Septic Arthritis

March 29, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigation on Diagnostic Criteria for Septic Arthritis：a Multi-center Nested Case-control Study

Septic arthritis (SA) is a rare but highly disabling disease. The ideal diagnosis criteria is not well established. There is an urgent need to establish golden standard for diagnosis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Septic arthritis (SA) is a rare but highly disabling disease. Epidemiologic studies have documented an incidence of 0.9-1.3 per 100,000 [1, 2]. The treatment is challenging and the ideal diagnosis criteria is not well established. The specific tactics employed by relevant researches varied widely [3-6]. Patients with recurrent sepsis may require arthrodesis or amputation, which would result in severe functional loss [2]. Therefore, there is an urgent need to establish golden standard for diagnosis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 300001
        • Recruiting
        • The First Affiliated Hospital of Zhejiang Chinese Medical University
        • Contact:
          • Mumingjiang Yishake, MD
          • Phone Number: +86-13868129151
      • Hangzhou, Zhejiang, China, 310053
        • Recruiting
        • Zhejiang Hospital
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

general hospital

Description

Inclusion Criteria:

  • admission to orthopaedics
  • complete data

Exclusion Criteria:

  • Accompanied with fracture
  • Accompanied with other infections
  • Accompanied with immune system diseases

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cases
Patients with septic arthritis
Diagnostic test: Laboratory test
including white blood cell count, C-reactive protein, erythrocyte sedimentation rate, percent of polymorphonuclear leukocytes, albumin, and globulin
Diagnostic test: History taking and physical examination
including fever, joint pain, local swelling and redness, sinus
Diagnostic test: biopsy
including arthrocentesis culture，and frozen section
Controls
Patients with osteoarthritis, rheumatoid arthritis
Diagnostic test: Laboratory test
including white blood cell count, C-reactive protein, erythrocyte sedimentation rate, percent of polymorphonuclear leukocytes, albumin, and globulin
Diagnostic test: History taking and physical examination
including fever, joint pain, local swelling and redness, sinus
Diagnostic test: biopsy
including arthrocentesis culture，and frozen section

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
WBC counts
Time Frame: preoperatively
white blood cell (WBC) counts
preoperatively
%PMN
Time Frame: preoperatively
percent of polymorphonuclear leukocytes (%PMN)
preoperatively
CRP
Time Frame: preoperatively
concentration of C-reactive protein (CRP)
preoperatively
ESR
Time Frame: preoperatively
erythrocyte sedimentation rate (ESR)
preoperatively
Albumin
Time Frame: preoperatively
concentration of albumin
preoperatively
Globulin
Time Frame: preoperatively
concentration of globulin
preoperatively
Body temperature
Time Frame: preoperatively
to check whether there has been a fever (>37.2°C) previously or now by medical history consultation and physical examination
preoperatively
joint swelling and redness
Time Frame: preoperatively
to check whether there is joint swelling and redness by visual inspection and palpation
preoperatively
sinus tract
Time Frame: preoperatively
to check whether there is any sinus tract by visual inspection
preoperatively
positive X-ray findings
Time Frame: preoperatively
to determine whether there are positive X-ray findings, such as bone destruction, narrowing of the joint space, etc.
preoperatively
positive MR findings
Time Frame: preoperatively
to determine whether there are positive MR findings, such as joint effusion, cartilage damage, etc.
preoperatively
positive pathological findings
Time Frame: intraoperatively
determined by 5 or more neutrophils per high-power field on histopathologic examination
intraoperatively
positive culture
Time Frame: preoperatively
determined by a bacterial growth when culture of blood or joint fluid in agarose
preoperatively

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The First Affiliated Hospital of Zhejiang Chinese Medical University
Zhejiang Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Lan Tang, MD, School of Medicine, Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 22, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-0909

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

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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