UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029613 |
|---|---|
| Receipt number | R000033828 |
| Scientific Title | Analysis of the expression of alpha-defensin in the joints of pyogenic arthritis |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2023/07/10 15:48:27 |
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Basic information
Public title
Analysis of the expression of alpha-defensin in the joints of pyogenic arthritis
Acronym
Analysis of the expression of alpha-defensin in the joints of pyogenic arthritis
Scientific Title
Analysis of the expression of alpha-defensin in the joints of pyogenic arthritis
Scientific Title:Acronym
Analysis of the expression of alpha-defensin in the joints of pyogenic arthritis
Region
| Japan |
Condition
Condition
Pyogenic arthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to determine alpha defensin in infectious cases after prosthetic joint surgery and synovia derived from afflicted joints of purulent arthritis cases and clarify alpha defensin upregulation in synovial fluid of affected joints .
Basic objectives2
Others
Basic objectives -Others
Comparison with the results of laboratory data and bacterial examination
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Increase of alpha defensin in infected joints
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Infection after artificial joint replacement surgery, cases of suppurative arthritis suspected
(2) Cases with local feeling of hotness, redness and swelling with physical findings
(3) Age: over 20 years old, under 80 years (at registration)
Key exclusion criteria
1) Patients wishing pregnant or pregnant
2) Persons who are participating in other clinical studies
3) In addition, patients who the doctor in charge judged as undesirable as subjects of this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Chiba |
Organization
Department of Orthopaedic Surgery, Graduate School of Medicine Tohoku University
Division name
Orthopaedic Surgery
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
0227177245
d-chiba@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Chiba |
Organization
Department of Orthopaedic Surgery, Graduate School of Medicine Tohoku University
Division name
Orthopaedic Surgery
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
812227177245
Homepage URL
d-chiba@med.tohoku.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Graduate School of Medicine Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic Surgery, Graduate School of Medicine Tohoku University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 12 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Analysis of the alpha defensin in the joints with infection
Management information
Registered date
| 2017 | Year | 10 | Month | 18 | Day |
Last modified on
| 2023 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033828
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
