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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013902
Receipt No. 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

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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
Institute Pomeranian Medical University in Szczecin
Institute
Department

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
URL(English) https://upload.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


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