UMIN-CTR Clinical Trial

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
Last 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
1st 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