UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of periprosthetic bone remodeling following, bone morphology, and stem fixation of the fully hydroxyapatite coated stem in primary total hip arthroplasty. -A randomized controlled trial-
Acronym	Comparison of two kinds of fully hydroxyapatite coated stem in primary total hip arthroplasty. -A randomized controlled trial-
Scientific Title	Comparison of periprosthetic bone remodeling following, bone morphology, and stem fixation of the fully hydroxyapatite coated stem in primary total hip arthroplasty. -A randomized controlled trial-
Scientific Title:Acronym	Comparison of periprosthetic bone remodeling following, bone morphology, and stem fixation of the fully hydroxyapatite coated stem in primary total hip arthroplasty. -A randomized controlled trial-
Region	Japan

Condition
Condition	osteoarthritis of the hip osteonecrosis of the femoral head
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of periprosthetic bone remodeling following, bone morphology, and stem fixation between fully hydroxyapatite coated Polar stem and fully hydroxyapatite coated Avenir stem in primary total hip arthroplasty. -A randomized controlled trial-
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	periprosthetic bone remodeling following
Key secondary outcomes	X-Ray examination clinical results

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	fully hydroxyapatite coated stem (Polar stem)
Interventions/Control_2	fully hydroxyapatite coated stem (Avenir stm)
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	40 years-old <=
Age-upper limit	80 years-old >
Gender	Female
Key inclusion criteria	osteoarthritis of the hip osteonecrosis of the hip
Key exclusion criteria	revision surgery severe osteoporosis pregnant woman lactating woman
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name Hirakawa
Organization	Shonan Kamakura Joint Reconstruction Center
Division name	Orthopaedic surgery
Zip code	247-0061
Address	5-4-17 Dai, Kamakura, Kanagawa
TEL	0467472377
Email	mail@skjrc.jp

Public contact
Name of contact person	1st name Masahiko Middle name Last name Mihara
Organization	Shonan Kamakura Joint Reconstruction Center
Division name	Orthopaedic surgery
Zip code	247-0061
Address	5-4-17 Dai, Kamakura, Kanagawa
TEL	0467472377
Homepage URL
Email	mail@skjrc.jp

Sponsor
Institute	Shonan Kamakura Joint Reconstruction Center
Institute
Department

Funding Source
Organization	Shonan Kamakura Joint Reconstruction Center
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	Mirai Iryo Research Center
Address	1-8-7, Koji-machi, Chiyoda-ku, Tokyo 102-0083, Japan
Tel	0332634801
Email	mirai-ec1@mirai-iryo.com

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	2020 Year 07 Month 01 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	Open public recruiting
Date of protocol fixation	2020 Year 06 Month 01 Day
Date of IRB	2020 Year 06 Month 03 Day
Anticipated trial start date	2020 Year 07 Month 01 Day
Last follow-up date	2026 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 05 Month 12 Day
Last modified on	2020 Year 08 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046068