AzTrials
AzTrials

Septic ArthritisNCT05790434

Diagnostic Criteria for Septic Arthritis

An observational study of Septic Arthritis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Septic Arthritis
What is being tested?
Laboratory test, History taking and physical examination and biopsy
How many people
400 participants
Where
2 sitesChina
Study dates
22 Feb 2022to 1 May 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: general hospital

Who may be able to join

  • admission to orthopaedics
  • complete data

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Rongxin He, PhD contact

+8657186518819

herongxin@zju.edu.cn

China2 sites, 2 recruiting

  • The First Affiliated Hospital of Zhejiang Chinese Medical University

    Hangzhou, Zhejiang, 300001

    Mumingjiang Yishake, MD, +86-13868129151

    Recruiting

  • Zhejiang hospital

    Hangzhou, Zhejiang, 310053

    Shuhui Cui, MD, +8618757169516, 21718254@zju.edu.cn

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Laboratory test, History taking and physical examination, biopsy
Keywords
Septic Arthritis, diagnostic criteria
Medical subject headings
Arthritis, Infectious

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laboratory testDiagnostic test

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

  • History taking and physical examinationDiagnostic test

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

  • biopsyDiagnostic test

    including arthrocentesis culture，and frozen section

Study groups in NCT05790434
Study groupRoleWhat they receive
CasesPatients with septic arthritis
Receives: Diagnostic Test: Laboratory test; Diagnostic Test: History taking and physical examination; Diagnostic Test: biopsy
ControlsPatients with osteoarthritis, rheumatoid arthritis
Receives: Diagnostic Test: Laboratory test; Diagnostic Test: History taking and physical examination; Diagnostic Test: biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. WBC counts

    white blood cell (WBC) counts

    Measured: preoperatively

  2. %PMN

    percent of polymorphonuclear leukocytes (%PMN)

    Measured: preoperatively

  3. CRP

    concentration of C-reactive protein (CRP)

    Measured: preoperatively

  4. ESR

    erythrocyte sedimentation rate (ESR)

    Measured: preoperatively

  5. Albumin

    concentration of albumin

    Measured: preoperatively

  6. Globulin

    concentration of globulin

    Measured: preoperatively

  7. Body temperature

    to check whether there has been a fever (>37.2°C) previously or now by medical history consultation and physical examination

    Measured: preoperatively

  8. joint swelling and redness

    to check whether there is joint swelling and redness by visual inspection and palpation

    Measured: preoperatively

  9. sinus tract

    to check whether there is any sinus tract by visual inspection

    Measured: preoperatively

  10. positive X-ray findings

    to determine whether there are positive X-ray findings, such as bone destruction, narrowing of the joint space, etc.

    Measured: preoperatively

  11. positive MR findings

    to determine whether there are positive MR findings, such as joint effusion, cartilage damage, etc.

    Measured: preoperatively

  12. positive pathological findings

    determined by 5 or more neutrophils per high-power field on histopathologic examination

    Measured: intraoperatively

  13. positive culture

    determined by a bacterial growth when culture of blood or joint fluid in agarose

    Measured: preoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2023
  2. Study start22 Feb 2022
  3. Primary completion1 May 2023 (estimated)
  4. Study completion1 May 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Other
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05790434
Sponsor's protocol ID
2022-0909
Status last verified
Feb 2023
First submitted
7 Feb 2023
Last updated
30 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 28366221

  • 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.

    PubMed 31862240

  • 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.

    PubMed 20206778

  • 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.

    PubMed 35747656

  • 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.

    PubMed 28291183

  • 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.

    PubMed 24599649

Questions about this trial

What is this clinical trial studying?

An observational study of Septic Arthritis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rongxin He, PhD (+8657186518819, herongxin@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

WBC counts (time frame: preoperatively). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05790434, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in