UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038744 |
|---|---|
| Receipt number | R000043993 |
| Scientific Title | The single center single cohort suevey of high protein jelly suplimant for the patients undergoing total knee arthroplasty. |
| Date of disclosure of the study information | 2019/12/02 |
| Last modified on | 2020/05/31 14:32:18 |
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Basic information
Public title
The suevey of high protein jelly suplimant for the patients undergoing total knee arthroplasty.
Acronym
high protein jelly total knee arthroplasty.
Scientific Title
The single center single cohort suevey of high protein jelly suplimant for the patients undergoing total knee arthroplasty.
Scientific Title:Acronym
TKAHprotSingle
Region
| Japan |
Condition
Condition
gonauthrosis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To eveluate for appropriate suplemental high protein jelly during rihabilitation after total knee arthroplasty.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
body weight,fomoral cicumference,ender leg circumference, serum albumin concentration, serum transthrethin concentration, serum cholin estrase concentration, peripheral white blood cell count, lymphocyte count, leg muscle strength, psychiatric test of POMR2,meal interviews
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
administration of high protein jelly
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
| 16 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients of proposed total knee arthroplasty
Key exclusion criteria
The patients who can not do the rehabilitation and can not do oral intake.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Takushi |
| Middle name | |
| Last name | Nakamura |
Organization
Toho University Omori Medical Center
Division name
orthpedics
Zip code
143-8541
Address
Omrori-Nishi 6-11-1, Ota-Ku, Tokyo, Japan
TEL
03-3762-4151
takashin@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Naohiro |
| Middle name | |
| Last name | Washizawa |
Organization
Toho University Omori Medical Center
Division name
Nutrition Therapy Center
Zip code
143-8541
Address
143
TEL
0337624151
Homepage URL
washi@med.toho-u.ac.jp
Sponsor or person
Institute
Department of orthopedics, Toho University Omori Medical Cente
Institute
Department
Personal name
Funding Source
Organization
Toho University Faculty of Medicine
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
Toho University Omori Medical Center
Address
Omori Nishi6-11-1, Ota-Ku, Tokyo, Japan
Tel
0337624151
omori.rinri@ext.toho-u.ac.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 | 12 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 30 | Day |
Last modified on
| 2020 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043993
