Diagnostic Criteria for Septic Arthritis

Recruiting

• Conditions: Septic Arthritis
• Interventions: Diagnostic Test: Laboratory test; Diagnostic Test: History taking and physical examination; Diagnostic Test: biopsy

• Registration Number: NCT05790434
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Study Start: 2022-02-22
• Status Verified: 2023-02
• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-03-29
• Last Update Submitted: 2023-03-29
• Study First Posted: 2023-03-30
• Last Update Posted: 2023-03-30
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• admission to orthopaedics
• complete data

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases	History taking and physical examination	Patients with septic arthritis
Cases	biopsy	Patients with septic arthritis
Controls	biopsy	Patients with osteoarthritis, rheumatoid arthritis
Controls	Laboratory test	Patients with osteoarthritis, rheumatoid arthritis
Controls	History taking and physical examination	Patients with osteoarthritis, rheumatoid arthritis
Cases	Laboratory test	Patients with septic arthritis

Primary Outcome Measures

Name	Time	Method
WBC counts	preoperatively	white blood cell (WBC) counts
CRP	preoperatively	concentration of C-reactive protein (CRP)
ESR	preoperatively	erythrocyte sedimentation rate (ESR)
%PMN	preoperatively	percent of polymorphonuclear leukocytes (%PMN)
joint swelling and redness	preoperatively	to check whether there is joint swelling and redness by visual inspection and palpation
positive MR findings	preoperatively	to determine whether there are positive MR findings, such as joint effusion, cartilage damage, etc.
positive pathological findings	intraoperatively	determined by 5 or more neutrophils per high-power field on histopathologic examination
Albumin	preoperatively	concentration of albumin
Globulin	preoperatively	concentration of globulin
Body temperature	preoperatively	to check whether there has been a fever (\>37.2°C) previously or now by medical history consultation and physical examination
sinus tract	preoperatively	to check whether there is any sinus tract by visual inspection
positive X-ray findings	preoperatively	to determine whether there are positive X-ray findings, such as bone destruction, narrowing of the joint space, etc.
positive culture	preoperatively	determined by a bacterial growth when culture of blood or joint fluid in agarose

Trial Locations

Locations (2)

The First Affiliated Hospital of Zhejiang Chinese Medical University; 🇨🇳 Hangzhou, Zhejiang, China

Zhejiang hospital; 🇨🇳 Hangzhou, Zhejiang, China