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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003278
Receipt No. R000003970
Scientific Title Evaluation of serum concentration of cytokine after operation with total hip arthroplasty
Date of disclosure of the study information 2010/03/09
Last modified on 2010/03/02

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Basic information
Public title Evaluation of serum concentration of cytokine after operation with total hip arthroplasty
Acronym Evaluation of serum concentration of cytokine after operation with total hip arthroplasty
Scientific Title Evaluation of serum concentration of cytokine after operation with total hip arthroplasty
Scientific Title:Acronym Evaluation of serum concentration of cytokine after operation with total hip arthroplasty
Region
Japan

Condition
Condition osteoarthritis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate implant type, we will analyze concentration of serum cytokine.
Basic objectives2 Others
Basic objectives -Others To evaluate implant type, we will analyze concentration of serum cytokine.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serum concentration of cytokines
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patient with total hip arthroplasty
Key exclusion criteria Patient with anemia
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinya Hayashi
Organization Department of Orthopaedic Surgery, Kobe University School of Medicine
Division name Orthopaedic Surgery
Zip code
Address 7-5-2 Kusunokicyo Cyuoku, Kobe Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinya Hayashi
Organization Kobe University School of Medicine
Division name Orthopaedic Surgery
Zip code
Address
TEL 078-382-5985
Homepage URL
Email

Sponsor
Institute Department of Orthopaedic Surgery, Kobe University School of Medicine
Institute
Department

Funding Source
Organization Department of Orthopaedic Surgery, Kobe University School of Medicine
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
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
2010 Year 03 Month 09 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
2010 Year 04 Month 10 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
2013 Year 05 Month 01 Day
Date trial data considered complete
2013 Year 05 Month 01 Day
Date analysis concluded
2013 Year 05 Month 01 Day

Other
Other related information Evaluation of serum cytokine concentration with patient after total hip arthroplasty

Management information
Registered date
2010 Year 03 Month 02 Day
Last modified on
2010 Year 03 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003970

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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