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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034997
Receipt No. 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 2019/05/28

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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
Middle name
Last name Hideki Ueyama
Organization Osaka City University Graduate School of Medicine
Division name Orthopedic surgery
Zip code
Address 1-4-3 asahimachi, abeno, Osaka, Japan
TEL +81-6-6645-3851
Email h.ueyama@msic.med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Ueyama
Organization Osaka City University Graduate School of Medicine
Division name Orthopedic surgery
Zip code
Address 1-4-3 asahimachi, abeno, Osaka, Japan
TEL +81-6-6645-3851
Homepage URL
Email h.ueyama@msic.med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Graduate School of Medicine, Orthopedic surgery
Institute
Department

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
Address
Tel
Email

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
Publication of results Unpublished

Result
URL related to results and publications
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
Participant flow
Adverse events
nothing
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
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
2019 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039908

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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