UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013902
Receipt number R000016209
Scientific Title Side effects of different tourniquets use during TKA.
Date of disclosure of the study information 2014/05/07
Last modified on 2014/05/07 19:13:57

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Basic information

Public title

Side effects of different tourniquets use during TKA.

Acronym

Comparison of different tourniquets used during TKA and their side effects

Scientific Title

Side effects of different tourniquets use during TKA.

Scientific Title:Acronym

Comparison of different tourniquets used during TKA and their side effects

Region

Europe


Condition

Condition

tourniquets use during TKA

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare different tourniquets used during TKA and their side effects

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To find more safe tourniquet and to improve postoperative rehabilitation

Key secondary outcomes



Base

Study type


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

tourniquet no 1

Interventions/Control_2

tourniquet no 2

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

18 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Gonarthrosis

Key exclusion criteria

any other concominant musculoskeletal disorders

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Pawe&#322; Zi&#281;tek

Organization

Pomeranian Medical University in Szczecin

Division name

Orthopaedics

Zip code


Address

Unii Lubelskiej 1, 71252 Szczecin Poland

TEL

+48509851888

Email

paulz@wp.pl


Public contact

Name of contact person

1st name
Middle name
Last name Maciej Karaczun

Organization

Pomeranian Medical University in Szczecin

Division name

Orthopaedics

Zip code


Address

Unii Lubelskiej 1, 71252 Szczecin Poland

TEL

+48602775701

Homepage URL


Email

karaczun@orthomail.com


Sponsor or person

Institute

Pomeranian Medical University in Szczecin

Institute

Department

Personal name



Funding Source

Organization

Pomeranian Medical University in Szczecin

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Poland


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



Other administrative information

Date of disclosure of the study information

2014 Year 05 Month 07 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

Enrolling by invitation

Date of protocol fixation

2014 Year 05 Month 07 Day

Date of IRB


Anticipated trial start date

2014 Year 05 Month 07 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 05 Month 07 Day

Last modified on

2014 Year 05 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016209


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name