UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Postoperative evaluation using different tourniquet cuff pressure in simultaneous bilateral total knee arthroplasty a double-blind randomised controlled trial~
Title of the study (Brief title)	Postoperative evaluation using different tourniquet cuff pressure in simultaneous bilateral total knee arthroplasty
Region	Japan

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

Objectives
Narrative objectives1	We investigate the postoperative clinical evaluation comparing randomly assigned the tourniquet pressure based on the conventional pressure and the limb occlusion pressure in simultaneous bilateral total knee arthroplasty.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in thigh pain from preoperative to 24 hours postoperatively.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Dose comparison
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	The tourniquet cuff pressure was decided by measuring the limb occlusion pressure.
Interventions/Control_2	The conventional tourniquet cuff pressure was 300mmHg.
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 scheduled for simultaneous bilateral primary total knee arthroplasty.
Key exclusion criteria	A patient who can not use tourniquet,who changed the tourniquet cuff pressure during surgery,and who judged that doctor is ineligible.
Target sample size	70

Research contact person
Name of lead principal investigator	Yoshiaki Okajima
Organization	Naniwa Ikuno Hospital
Division name	Joint Reconstruction Center
Address	1-10-3 Daikoku Naniwa-ku Osaka-shi Japan 556-0014
TEL	06-6632-9915
Email	okapy915@zeus.eonet.ne.jp

Public contact
Name of contact person	Kenka Ra
Organization	Naniwa Ikuno Hospital
Division name	Joint Reconstruction Center
Address	1-10-3 Daikoku Naniwa-ku Osaka-shi Japan 556-0014
TEL	06-6632-9915
Homepage URL
Email	l_c_h_4160@yahoo.co.jp

Sponsor
Institute	Naniwa Ikuno Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	なにわ生野病院

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 09 Month 26 Day
Anticipated trial start date	2017 Year 10 Month 01 Day
Last follow-up date	2018 Year 04 Month 30 Day
Date of closure to data entry	2018 Year 05 Month 31 Day
Date trial data considered complete	2018 Year 05 Month 31 Day
Date analysis concluded	2018 Year 05 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 09 Month 25 Day
Last modified on	2017 Year 09 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033476