NCT06241365

Brief Summary

Purpose: C-reactive protein to albumin ratio (CAR) has emerged as a novel marker of inflammation. However, almost no research has evaluated the role of CAR in septic arthritis (SA). There is currently controversy over the timing of surgery. Our aim is to explore the application of the CAR in predicting the treatment choice for SA in children under 4 years of age. Methods: Retrospective analysis of the clinical data from children under four years of age admitted to the Department of Orthopedics at Children's Hospital of Soochow University between January 2016 and December 2022 due to SA. Patients were divided into surgery group and conservative group based on whether the patients underwent surgery. The clinical data of the two groups were compared. Multivariate logistic regression analysis was performed to determine the independent predictors for SA requiring surgical intervention. Receiver operating characteristic (ROC) curves were plotted for the independent predictive indicators, and the area under curve (AUC) was determined. The cut-off value was determined using Youden index, and diagnostic accuracy indicators such as sensitivity (SEN), specificity (SPE), positive predictive value (PPV) and negative predictive value (NPV) were calculated.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2016

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
Last Updated

February 14, 2025

Status Verified

February 1, 2025

Enrollment Period

7 years

First QC Date

January 28, 2024

Last Update Submit

February 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • CAR

    CAR is an independent predictor indicator for surgery and has good predictive accuracy in chlidren under four years of age with SA.

    December 2022

Study Arms (2)

surgery group

Patients were divided into surgery group and conservative group based on whether the patients underwent surgery.

conservative group

Patients were divided into surgery group and conservative group based on whether the patients underwent surgery.

Eligibility Criteria

Age1 Day - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The investigators reviewed the clinical records of patients under 4 years old with SA who were admitted to the Department of Orthopedics at the Children's Hospital of Soochow University for SA treatment between January 2016 and December 2022.

You may qualify if:

  • (1) Meeting the aforementioned SA diagnostic criteria, regardless of the affected joint; (2) Completing routine blood and biochemical tests within 24 hours of admission; (3) No surgery or antibiotics administered prior to admission.

You may not qualify if:

  • (1) Cases of transient synovitis, rheumatism-related diseases (JIA, etc.), simple acute hematogenous osteomyelitis, or acute exacerbation of chronic hematogenous osteomyelitis after revision of the diagnosis; (2) Postoperative iatrogenic infection; (3) Incomplete clinical data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Infectious

Condition Hierarchy (Ancestors)

InfectionsArthritisJoint DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

January 28, 2024

First Posted

February 5, 2024

Study Start

January 5, 2016

Primary Completion

December 18, 2022

Study Completion

December 1, 2023

Last Updated

February 14, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL