UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057767 |
|---|---|
| Receipt number | R000065842 |
| Scientific Title | Retrospective diagnostic accuracy study on the clinical utility of preceding fever or shaking chills for diagnosing septic arthritis in acute monoarthritis |
| Date of disclosure of the study information | 2025/05/06 |
| Last modified on | 2025/05/03 16:58:14 |
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Basic information
Public title
Study on the usefulness of preceding fever or shaking chills in identifying septic arthritis among patients with acute monoarthritis
Acronym
PREF-SA Study (PReceding Fever for Septic Arthritis study)
Scientific Title
Retrospective diagnostic accuracy study on the clinical utility of preceding fever or shaking chills for diagnosing septic arthritis in acute monoarthritis
Scientific Title:Acronym
PREF-SA study (PReceding Fever for Septic Arthritis study)
Region
| Japan |
Condition
Condition
septic arthritis
Classification by specialty
| Medicine in general | Clinical immunology | Infectious disease |
| Orthopedics | Emergency medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To improve the quality of clinical care for acute monoarthritis in the emergency department by establishing new diagnostic evidence through the calculation of sensitivity, specificity, and likelihood ratios of various clinical features and risk factors, such as fever, shaking chills, and medical history, for the diagnosis of septic arthritis.
Basic objectives2
Others
Basic objectives -Others
This is a diagnostic accuracy study aiming to evaluate the usefulness of preceding fever or shaking chills, as well as other clinical factors, for identifying septic arthritis among patients with acute monoarthritis. Sensitivity, specificity, and likelihood ratios of each factor will be calculated.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic performance (sensitivity, specificity, and likelihood ratios) of preceding fever or shaking chills for identifying septic arthritis in patients with acute monoarthritis
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient inclusion criteria were all of the following: (a) age of 18 years or older; (b) no penetrating joint injury; (c) no history of affected joint surgery within one year; (d) no prosthetic implantation of the affected joint; and (e) joint aspiration was performed and synovial fluid was submitted for analysis in the emergency department.
Key exclusion criteria
Patients were excluded if they met any of the following criteria: (a) joint aspiration was performed but no synovial fluid was obtained and submitted for analysis (i.e., dry tap); (b) diagnosis of bursitis instead of arthritis; (c) diagnosis of tuberculous arthritis.
Target sample size
224
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Kano |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Department of Emergency and General Medicine
Zip code
1838524
Address
2-8-29 Musashidai, Fuchu, Tokyo 183-8524, Japan
TEL
09074238717
yasuhiro.kano.21@gmail.com
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Kano |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Department of Emergency and General Medicine
Zip code
1838524
Address
2-8-29 Musashidai, Fuchu, Tokyo 183-8524, Japan
TEL
09074238717
Homepage URL
yasuhiro.kano.21@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Tama Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Tama Medical Center
Address
2-8-29 Musashidai, Fuchu, Tokyo 183-8524, Japan
Tel
(+81)42-323-5111
yasuhiro.kano.21@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 02 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 05 | Month | 31 | Day |
Other
Other related information
Review of medical records
Management information
Registered date
| 2025 | Year | 05 | Month | 03 | Day |
Last modified on
| 2025 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065842
