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Name
UMIN ID

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017610
Receipt No. 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

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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
Email 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
Email ykatsura@hosp.ncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

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
Email 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
URL(English) 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


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