Clinical trial NCT05790434: Diagnostic Criteria for Septic Arthritis
Official title: Investigation on Diagnostic Criteria for Septic Arthritis：a Multi-center Nested Case-control Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Septic Arthritis
Keywords: Septic Arthritis
diagnostic criteria
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Zhejiang Hospital
name: The First Affiliated Hospital of Zhejiang Chinese Medical University
First posted: 2023-03-30
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: general hospital

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.

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.

Eligibility criteria: Inclusion Criteria:

* admission to orthopaedics
* complete data

Exclusion Criteria:

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

Primary outcomes:
measure: WBC counts
timeFrame: preoperatively
measure: %PMN
timeFrame: preoperatively
measure: CRP
timeFrame: preoperatively
measure: ESR
timeFrame: preoperatively
measure: Albumin
timeFrame: preoperatively
measure: Globulin
timeFrame: preoperatively
measure: Body temperature
timeFrame: preoperatively
measure: joint swelling and redness
timeFrame: preoperatively
measure: sinus tract
timeFrame: preoperatively
measure: positive X-ray findings
timeFrame: preoperatively
measure: positive MR findings
timeFrame: preoperatively
measure: positive pathological findings
timeFrame: intraoperatively
measure: positive culture
timeFrame: preoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang hospital
state: Zhejiang
Study officials:
affiliation: School of Medicine, Zhejiang University
name: Lan Tang, MD
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.
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.
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.
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.