UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of the effect of steroid therapy in total knee arthroplasty
Acronym	Comparison of the effect of steroid therapy in TKA
Scientific Title	Comparison of the effect of steroid therapy in total knee arthroplasty
Scientific Title:Acronym	Comparison of the effect of steroid therapy in TKA
Region	Japan

Condition
Condition	Osteoarthritis knee
Classification by specialty	Orthopedics Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purposes of this study are to compare the anti-inflammatory and anti-emetic, anti-thrombogenic effects between topical intra-articular steroid and intravenous steroid during total knee arthroplasty.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	IL-6 value in the blood 24 hours after surgery
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
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	Medicine
Interventions/Control_1	The intravenous group received 10ml of physiological saline solution containing 10mg dexamethasone one hour before surgery and 24 hours after suregery
Interventions/Control_2	The intraarticular group received periarticular injection of 40mg triamcinolone acetate during surgery.
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	50 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	end stage osteoarthritis knee
Key exclusion criteria	DM, RA, Oral intake of corticosteroid or anticoagulant
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kazuhisa Middle name Last name Hatayama
Organization	Medical office
Division name	Orthopaedic surgery
Zip code	371-0025
Address	1-7-13, Koun
TEL	0272218165
Email	hatayaman@gmail.com

Public contact
Name of contact person	1st name Kazuhisa Middle name Last name Hatayama
Organization	Medical office
Division name	Orthopaedic surgery
Zip code	3710025
Address	1-7-13, Koun, Maebashi
TEL	0272218165
Homepage URL
Email	hatayaman@gmail.com

Sponsor
Institute	Orthopaedic surgery, JCHO gunma central hospital
Institute
Department

Funding Source
Organization	None
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	JCHO Gunma central hospital, hospital ethics committee
Address	1-7-23, Koun Maebashi
Tel	0272218165
Email	yakuzai-di@gunma.jcho.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	2019 Year 09 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	Completed
Date of protocol fixation	2018 Year 07 Month 25 Day
Date of IRB	2018 Year 06 Month 20 Day
Anticipated trial start date	2019 Year 07 Month 25 Day
Last follow-up date	2021 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 09 Month 02 Day
Last modified on	2021 Year 09 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038155