UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029287
Receipt number R000033476
Scientific Title Postoperative evaluation using different tourniquet cuff pressure in simultaneous bilateral total knee arthroplasty a double-blind randomised controlled trial~
Date of disclosure of the study information 2017/10/01
Last modified on 2017/09/25 22:00:01

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Basic information

Public title

Postoperative evaluation using different tourniquet cuff pressure in simultaneous bilateral total knee arthroplasty a double-blind randomised controlled trial~

Acronym

Postoperative evaluation using different tourniquet cuff pressure in simultaneous bilateral total knee arthroplasty

Scientific Title

Postoperative evaluation using different tourniquet cuff pressure in simultaneous bilateral total knee arthroplasty a double-blind randomised controlled trial~

Scientific Title:Acronym

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

1st name
Middle name
Last name Yoshiaki Okajima

Organization

Naniwa Ikuno Hospital

Division name

Joint Reconstruction Center

Zip code


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

1st name
Middle name
Last name Kenka Ra

Organization

Naniwa Ikuno Hospital

Division name

Joint Reconstruction Center

Zip code


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 or person

Institute

Naniwa Ikuno Hospital

Institute

Department

Personal name



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)



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

なにわ生野病院


Other administrative information

Date of disclosure of the study information

2017 Year 10 Month 01 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

Preinitiation

Date of protocol fixation

2017 Year 09 Month 26 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033476


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name