NCT05790434

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

March 30, 2023

Status Verified

February 1, 2023

Enrollment Period

1.2 years

First QC Date

February 7, 2023

Last Update Submit

March 29, 2023

Conditions

Septic Arthritis

Keywords

Septic Arthritisdiagnostic criteria

Outcome Measures

Primary Outcomes (13)

  • 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

Study Arms (2)

Cases

Patients with septic arthritis

Diagnostic Test: Laboratory testDiagnostic Test: History taking and physical examinationDiagnostic Test: biopsy

Controls

Patients with osteoarthritis, rheumatoid arthritis

Diagnostic Test: Laboratory testDiagnostic Test: History taking and physical examinationDiagnostic Test: biopsy

Interventions

Laboratory testDIAGNOSTIC_TEST

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

CasesControls
History taking and physical examinationDIAGNOSTIC_TEST

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

CasesControls
biopsyDIAGNOSTIC_TEST

including arthrocentesis culture，and frozen section

CasesControls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

general hospital

You may qualify if:

  • admission to orthopaedics
  • complete data

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 300001, China

RECRUITING

Zhejiang hospital

Hangzhou, Zhejiang, 310053, China

RECRUITING

Related Publications (6)

  • 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.

    PMID: 28366221BACKGROUND

  • 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.

    PMID: 31862240BACKGROUND

  • 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.

    PMID: 20206778BACKGROUND

  • 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.

    PMID: 35747656BACKGROUND

  • 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.

    PMID: 28291183BACKGROUND

  • 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.

    PMID: 24599649BACKGROUND

MeSH Terms

Conditions

Arthritis, Infectious

Interventions

Clinical Laboratory TechniquesPhysical ExaminationBiopsy

Condition Hierarchy (Ancestors)

InfectionsArthritisJoint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesCytodiagnosisCytological TechniquesSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, Operative

Study Officials

  • Lan Tang, MD

    School of Medicine, Zhejiang University

    STUDY DIRECTOR

Central Study Contacts

Rongxin He, PhD

CONTACT

+8657186518819herongxin@zju.edu.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2023

First Posted

March 30, 2023

Study Start

February 22, 2022

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

March 30, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)