UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037896 |
|---|---|
| Receipt number | R000038155 |
| Scientific Title | Comparison of the effect of steroid therapy in total knee arthroplasty |
| Date of disclosure of the study information | 2019/09/02 |
| Last modified on | 2021/09/03 12:53:18 |
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Basic information
Public title
Comparison of the effect of steroid therapy in total knee arthroplasty
Acronym
Comparison of the effect of steroid therapy in TKA
Scientific Title
Comparison of the effect of steroid therapy in total knee arthroplasty
Scientific Title:Acronym
Comparison of the effect of steroid therapy in TKA
Region
| Japan |
Condition
Condition
Osteoarthritis knee
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purposes of this study are to compare the anti-inflammatory and anti-emetic, anti-thrombogenic effects between topical intra-articular steroid and intravenous steroid during total knee arthroplasty.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IL-6 value in the blood 24 hours after surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The intravenous group received 10ml of physiological saline solution containing 10mg dexamethasone one hour before surgery and 24 hours after suregery
Interventions/Control_2
The intraarticular group received periarticular injection of 40mg triamcinolone acetate during surgery.
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
end stage osteoarthritis knee
Key exclusion criteria
DM, RA, Oral intake of corticosteroid or anticoagulant
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuhisa |
| Middle name | |
| Last name | Hatayama |
Organization
Medical office
Division name
Orthopaedic surgery
Zip code
371-0025
Address
1-7-13, Koun
TEL
0272218165
hatayaman@gmail.com
Public contact
Name of contact person
| 1st name | Kazuhisa |
| Middle name | |
| Last name | Hatayama |
Organization
Medical office
Division name
Orthopaedic surgery
Zip code
3710025
Address
1-7-13, Koun, Maebashi
TEL
0272218165
Homepage URL
hatayaman@gmail.com
Sponsor or person
Institute
Orthopaedic surgery, JCHO gunma central hospital
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
JCHO Gunma central hospital, hospital ethics committee
Address
1-7-23, Koun Maebashi
Tel
0272218165
yakuzai-di@gunma.jcho.go.jp
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
| 2019 | Year | 09 | Month | 02 | 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
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 02 | Day |
Last modified on
| 2021 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038155
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