Diagnostic Criteria for Septic Arthritis

NCT ID: NCT05790434

Last Updated: 2023-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-22

Study Completion Date

2023-05-01

Brief Summary

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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

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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.

Conditions

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Septic Arthritis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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Cases

Patients with septic arthritis

Laboratory test

Intervention Type DIAGNOSTIC_TEST

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

History taking and physical examination

Intervention Type DIAGNOSTIC_TEST

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

biopsy

Intervention Type DIAGNOSTIC_TEST

including arthrocentesis culture,and frozen section

Controls

Patients with osteoarthritis, rheumatoid arthritis

Laboratory test

Intervention Type DIAGNOSTIC_TEST

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

History taking and physical examination

Intervention Type DIAGNOSTIC_TEST

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

biopsy

Intervention Type DIAGNOSTIC_TEST

including arthrocentesis culture,and frozen section

Interventions

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Laboratory test

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

Intervention Type DIAGNOSTIC_TEST

History taking and physical examination

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

Intervention Type DIAGNOSTIC_TEST

biopsy

including arthrocentesis culture,and frozen section

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* admission to orthopaedics
* complete data

Exclusion Criteria

* Accompanied with fracture
* Accompanied with other infections
* Accompanied with immune system diseases
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhejiang Chinese Medical University

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lan Tang, MD

Role: STUDY_DIRECTOR

School of Medicine, Zhejiang University

Locations

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The First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Zhejiang hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Rongxin He, PhD

Role: CONTACT

+8657186518819

Facility Contacts

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Mumingjiang Yishake, MD

Role: primary

+86-13868129151

Shuhui Cui, MD

Role: primary

+8618757169516

References

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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.

Reference Type BACKGROUND
PMID: 28366221 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31862240 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20206778 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35747656 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28291183 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24599649 (View on PubMed)

Other Identifiers

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2022-0909

Identifier Type: -

Identifier Source: org_study_id

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