UMIN-CTR Clinical Trial

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
Email	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
Email	h.ueyama@msic.med.osaka-cu.ac.jp

Sponsor
Institute	Tanabe Central Hospital, 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	IRB at Tanabe Central Hospital
Address	147 minamishinmachi, Tanabe, Wakayama, Japan
Tel	+81-739-24-5333
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039908