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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036301
Receipt No. R000041363
Scientific Title Comparison of Bone Reaction between Two Type of Stem for the Champange Flute Canal.
Date of disclosure of the study information 2019/03/26
Last modified on 2019/03/26

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Basic information
Public title Comparison of Bone Reaction between Two Type of Stem for the Champange Flute Canal.
Acronym Comparison of Bone Reaction between Two Type of Stem for the Champange Flute Canal.
Scientific Title Comparison of Bone Reaction between Two Type of Stem for the Champange Flute Canal.
Scientific Title:Acronym Comparison of Bone Reaction between Two Type of Stem for the Champange Flute Canal.
Region
Japan

Condition
Condition Hip Orthoarthritis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Observe and evaluate the differences in bone response of patients who were inserted two similar shapes of cementless stems.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluate bone reaction at 5 years after surgery between both stems and examine differences in appearance of Stress Sheilding
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Employ the Taper Loc Complete Microplasty (Zimmer Biomet)
Interventions/Control_2 Employ the Ovation Tribute (Ortho Development)
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Champange Flute Canal
Key exclusion criteria over 50 degree of femoral anteversion
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Naoyuki
Middle name
Last name Hirasawa
Organization Hokusuikai Kinen Hospital
Division name Orthopaedic surgery
Zip code 310-0035
Address 3-2-1 Higashihara, Mito, Ibaraki 310-0035, Japan
TEL 0293033003
Email hirari3@orion.ocn.ne.jp

Public contact
Name of contact person
1st name Naoyuki
Middle name
Last name Hirasawa
Organization Hokusuikai Kinen Hospital
Division name Orthopaedic surgery
Zip code 310-0035
Address 3-2-1 Higashihara, Mito, Ibaraki 310-0035, Japan
TEL 0293033003
Homepage URL
Email hirari3@orion.ocn.ne.jp

Sponsor
Institute Hokusuikai Kinen Hospital
Institute
Department

Funding Source
Organization Japan MDM
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Hokusuikai Kinen Hospital
Address 3-2-1 Higashihara, Mito, Ibaraki 310-0035, Japan
Tel 029-303-3003
Email hakoda@hokusuikai-kinen.jp

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
2019 Year 03 Month 26 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 44
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 No longer recruiting
Date of protocol fixation
2016 Year 02 Month 17 Day
Date of IRB
2017 Year 02 Month 17 Day
Anticipated trial start date
2017 Year 03 Month 02 Day
Last follow-up date
2022 Year 12 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 03 Month 26 Day
Last modified on
2019 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041363

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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