UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017610 |
|---|---|
| Receipt number | R000020411 |
| Scientific Title | Evaluation of the thermal effect of lavage for arthroplasty |
| Date of disclosure of the study information | 2015/05/20 |
| Last modified on | 2020/05/28 18:04:59 |
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Basic information
Public title
Evaluation of the thermal effect of lavage for arthroplasty
Acronym
Evaluation of the thermal effect of lavage for arthroplasty
Scientific Title
Evaluation of the thermal effect of lavage for arthroplasty
Scientific Title:Acronym
Evaluation of the thermal effect of lavage for arthroplasty
Region
| Japan |
Condition
Condition
osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the thermal effect of lavage for arthroplasty
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postoperative pain, progress of rehabilitation, blood examination
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
| Maneuver |
Interventions/Control_1
lavage temperature at 4 degree celsius
Interventions/Control_2
lavage temperature at 36 degree celsius
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
| 40 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
arthroplasty patients
Key exclusion criteria
No
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yozo |
| Middle name | |
| Last name | Katsuragawa |
Organization
National Center for Global Health and Medicine
Division name
Orthopedics
Zip code
162-8655
Address
1-21-1 Toyama, Shinjuku-ku, TOKYO
TEL
03-3202-7181
ykatsura@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Yozo |
| Middle name | |
| Last name | Katsuragawa |
Organization
National Center for Global Health and Medicine
Division name
Orthopedics
Zip code
162-8655
Address
1-21-1 Toyama, Shinjuku-ku, TOKYO
TEL
03-3202-7181
Homepage URL
ykatsura@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
No
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
National Center for Global Health and Medicine
Address
1-21-1 Toyama Shinjuku-ku TOKYO
Tel
03-3202-7181
rinrijm@hosp.ncgm.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
| 2015 | Year | 05 | Month | 20 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000020411
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000020411
Number of participants that the trial has enrolled
194
Results
No significant difference was seen between two groups
Results date posted
| 2020 | Year | 05 | Month | 28 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
no significant result was seen
Date of the first journal publication of results
Baseline Characteristics
arthroplasty patients
Participant flow
arthroplasty patients were explained about the study and enrolled.
Adverse events
no
Outcome measures
postoperative pain
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2015 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 18 | Day |
Last modified on
| 2020 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020411
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
