Diagnostic Criteria for Septic Arthritis

Septic Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05790434
• Other study ID #: 2022-0909
• Status: Recruiting
• Start date: February 22, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: February 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Rongxin He, PhD
• Phone: +8657186518819
• Email: herongxin[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• admission to orthopaedics

• complete data

Exclusion Criteria:

• Accompanied with fracture

• Accompanied with other infections

• Accompanied with immune system diseases

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Infectious
• Septic Arthritis

Intervention

Diagnostic Test:
• Laboratory test
including white blood cell count, C-reactive protein, erythrocyte sedimentation rate, percent of polymorphonuclear leukocytes, albumin, and globulin
• History taking and physical examination
including fever, joint pain, local swelling and redness, sinus
• biopsy
including arthrocentesis culture,and frozen section

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Zhejiang Chinese Medical University	Hangzhou	Zhejiang
China	Zhejiang hospital	Hangzhou	Zhejiang

Sponsors (3)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	The First Affiliated Hospital of Zhejiang Chinese Medical University, Zhejiang Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

Abram SGF, Alvand A, Judge A, Beard DJ, Price AJ. Mortality and adverse joint outcomes following septic arthritis of the native knee: a longitudinal cohort study of patients receiving arthroscopic washout. Lancet Infect Dis. 2020 Mar;20(3):341-349. doi: 10.1016/S1473-3099(19)30419-0. Epub 2019 Dec 17. — View Citation

Johns BP, Loewenthal MR, Dewar DC. Open Compared with Arthroscopic Treatment of Acute Septic Arthritis of the Native Knee. J Bone Joint Surg Am. 2017 Mar 15;99(6):499-505. doi: 10.2106/JBJS.16.00110. — View Citation

Mathews CJ, Weston VC, Jones A, Field M, Coakley G. Bacterial septic arthritis in adults. Lancet. 2010 Mar 6;375(9717):846-55. doi: 10.1016/S0140-6736(09)61595-6. — View Citation

Padaki AS, Ma GC, Truong NM, Cogan CJ, Lansdown DA, Feeley BT, Ma CB, Zhang AL. Arthroscopic Treatment Yields Lower Reoperation Rates than Open Treatment for Native Knee but Not Native Shoulder Septic Arthritis. Arthrosc Sports Med Rehabil. 2022 May 27;4(3):e1167-e1178. doi: 10.1016/j.asmr.2022.04.014. eCollection 2022 Jun. — View Citation

Ross JJ. Septic Arthritis of Native Joints. Infect Dis Clin North Am. 2017 Jun;31(2):203-218. doi: 10.1016/j.idc.2017.01.001. Epub 2017 Mar 30. — View Citation

Shaikh AA, Ha CW, Park YG, Park YB. Two-stage approach to primary TKA in infected arthritic knees using intraoperatively molded articulating cement spacers. Clin Orthop Relat Res. 2014 Jul;472(7):2201-7. doi: 10.1007/s11999-014-3545-6. Epub 2014 Mar 6. — View Citation

Outcome

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