UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034997 |
|---|---|
| Receipt number | R000039908 |
| Scientific Title | The effect of nutrition treatment for rectus femoris after total knee arthroplasty -randomized control trial- |
| Date of disclosure of the study information | 2018/11/26 |
| Last modified on | 2021/07/14 13:08:33 |
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Basic information
Public title
The effect of nutrition treatment for rectus femoris after total knee arthroplasty -randomized control trial-
Acronym
The effect of nutrition treatment for rectus femoris after total knee arthroplasty -randomized control trial-
Scientific Title
The effect of nutrition treatment for rectus femoris after total knee arthroplasty -randomized control trial-
Scientific Title:Acronym
The effect of nutrition treatment for rectus femoris after total knee arthroplasty -randomized control trial-
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The analysis of efficacy of amino acid supplementation in quadriceps after total knee arthroplasy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The area of rectus femoris before TKA and after TKA (in 1, 2, 3, and 4 weeks after operation). This area will be measured by using ultrasonography.
Key secondary outcomes
walking speed, muscle strength of quadriceps, Knee society score, and patient satisfaction
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Two groups are assigned, and amino acids are administered to one group of patients. Essential amino acid supplementation at peri-operative period will be done. Patients take amino acids from 1 week before operation to 2 weeks after operation. Regimen is 2 g each after each meal, totaling 6 g in a day per one patient.
Interventions/Control_2
Two groups are assigned, and lactose are administered to one group of patients. Lactose supplementation at peri-operative period will be done. Patients take lactose from 1 week before operation to 2 weeks after operation. Regimen is 2 g each after each meal, totaling 6 g in a day per one patient. This group will be defined placebo group.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing TKA surgery due to osteoarthritis of the knee
Key exclusion criteria
A patient who has liver disease and is not suitable for amino acid administration. Patient who refused to be subject to clinical study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Ueyama |
Organization
Osaka City University Graduate School of Medicine, Tanabe Central Hospital
Division name
Orthopedic surgery
Zip code
545-8585
Address
1-4-3 asahimachi, abeno, Osaka, Japan
TEL
+81-6-6645-3851
h.ueyama@msic.med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Ueyama |
Organization
Osaka City University Graduate School of Medicine
Division name
Orthopedic surgery
Zip code
545-8585
Address
1-4-3 asahimachi, abeno, Osaka, Japan
TEL
+81-6-6645-3851
Homepage URL
h.ueyama@msic.med.osaka-cu.ac.jp
Sponsor or person
Institute
Tanabe Central Hospital, Orthopedic surgery
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tanabe central hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB at Tanabe Central Hospital
Address
147 minamishinmachi, Tanabe, Wakayama, Japan
Tel
+81-739-24-5333
y.taniguchi000@gmail.com
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
大阪市立大学附属病院(大阪府)、田辺中央病院(和歌山県)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 26 | Day |
Related information
URL releasing protocol
Bone joint journal
Publication of results
Published
Result
URL related to results and publications
Bone joint journal
Number of participants that the trial has enrolled
67
Results
US revealed the area of muscle in femoral became atrophy after TKA.
Results date posted
| 2019 | Year | 05 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
local populations
Participant flow
free access
Adverse events
nothing
Outcome measures
rectus femoris muscle area
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 26 | Day |
Last modified on
| 2021 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039908
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