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Diagnostic Criteria for Septic Arthritis

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05790434
Enrollment
400
Registered
2023-03-30
Start date
2022-02-22
Completion date
2023-05-01
Last updated
2023-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Arthritis

Keywords

Septic Arthritis, diagnostic criteria

Brief summary

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.

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.

Interventions

DIAGNOSTIC_TESTHistory taking and physical examination

including fever, joint pain, local swelling and redness, sinus

DIAGNOSTIC_TESTbiopsy

including arthrocentesis culture,and frozen section

DIAGNOSTIC_TESTLaboratory test

including white blood cell count, C-reactive protein, erythrocyte sedimentation rate, percent of polymorphonuclear leukocytes, albumin, and globulin

Sponsors

Zhejiang Hospital
CollaboratorOTHER
The First Affiliated Hospital of Zhejiang Chinese Medical University
CollaboratorOTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* admission to orthopaedics * complete data

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
WBC countspreoperativelywhite blood cell (WBC) counts
%PMNpreoperativelypercent of polymorphonuclear leukocytes (%PMN)
CRPpreoperativelyconcentration of C-reactive protein (CRP)
ESRpreoperativelyerythrocyte sedimentation rate (ESR)
Albuminpreoperativelyconcentration of albumin
Globulinpreoperativelyconcentration of globulin
Body temperaturepreoperativelyto check whether there has been a fever (\>37.2°C) previously or now by medical history consultation and physical examination
joint swelling and rednesspreoperativelyto check whether there is joint swelling and redness by visual inspection and palpation
sinus tractpreoperativelyto check whether there is any sinus tract by visual inspection
positive X-ray findingspreoperativelyto determine whether there are positive X-ray findings, such as bone destruction, narrowing of the joint space, etc.
positive MR findingspreoperativelyto determine whether there are positive MR findings, such as joint effusion, cartilage damage, etc.
positive pathological findingsintraoperativelydetermined by 5 or more neutrophils per high-power field on histopathologic examination
positive culturepreoperativelydetermined by a bacterial growth when culture of blood or joint fluid in agarose

Countries

China

Contacts

Primary ContactRongxin He, PhD
herongxin@zju.edu.cn+8657186518819

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026