Diagnostic Criteria for Septic Arthritis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Septic Arthritis
• Intervention / Treatment: Diagnostic test: Laboratory test; Diagnostic test: History taking and physical examination; Diagnostic test: biopsy

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 Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Rongxin He, PhD; Phone Number: +8657186518819; Email: herongxin@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 300001
      • Recruiting
      • The First Affiliated Hospital of Zhejiang Chinese Medical University
      • Contact: Mumingjiang Yishake, MD; Phone Number: +86-13868129151
    • Hangzhou, Zhejiang, China, 310053
      • Recruiting
      • Zhejiang Hospital
      • Contact: Shuhui Cui, MD; Phone Number: +8618757169516; Email: 21718254@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

general hospital

Description

Inclusion Criteria:

• admission to orthopaedics
• complete data

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases; Patients with septic arthritis	Diagnostic test: Laboratory test; including white blood cell count, C-reactive protein, erythrocyte sedimentation rate, percent of polymorphonuclear leukocytes, albumin, and globulin; Diagnostic test: History taking and physical examination; including fever, joint pain, local swelling and redness, sinus; Diagnostic test: biopsy; including arthrocentesis culture，and frozen section
Controls; Patients with osteoarthritis, rheumatoid arthritis	Diagnostic test: Laboratory test; including white blood cell count, C-reactive protein, erythrocyte sedimentation rate, percent of polymorphonuclear leukocytes, albumin, and globulin; Diagnostic test: History taking and physical examination; including fever, joint pain, local swelling and redness, sinus; Diagnostic test: biopsy; including arthrocentesis culture，and frozen section

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: The First Affiliated Hospital of Zhejiang Chinese Medical University; Zhejiang Hospital
• Investigators: Study Director: Lan Tang, MD, School of Medicine, Zhejiang University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: March 29, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: diagnostic criteria; Septic Arthritis
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Arthritis, Infectious
• Other Study ID Numbers: 2022-0909

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No