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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06241365
Other study ID # 2021KS024
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 5, 2016
Est. completion date December 1, 2023

Study information

Verified date January 2024
Source Children's Hospital of Soochow University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 they 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.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date December 1, 2023
Est. primary completion date December 18, 2022
Accepts healthy volunteers No
Gender All
Age group 1 Day to 4 Years
Eligibility Inclusion Criteria: - (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. Exclusion Criteria: - (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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
wangxiaodong

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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