UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of bone remodeling between HA coated new implant and conventional implant using 18F-fluoride PET and DEXA
Acronym	PET/DEXA THA study HA vs non HA
Scientific Title	Comparison of bone remodeling between HA coated new implant and conventional implant using 18F-fluoride PET and DEXA
Scientific Title:Acronym	PET/DEXA THA study HA vs non HA
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 bone remodeling between Hydroxyapatite coated new implant and conventional implant using 18F-fluoride PET and DEXA
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Evaluation of periprosthetic bone mineral density(zero weeks, 24 weeks and 48 weeks after THA) using DEXA. Evaluation of periprosthetic SUVmax(24 weeeks after THA) using 18F-fluoride PET scan.
Key secondary outcomes	Comparison of clinical scores between Hydroxyapatite coated implant and conventional implant.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Group that has implants with Hydroxyapatite coating on the proximal region of its stem.
Interventions/Control_2	Group that has conventional implants with no Hydroxyapatite coating on the proximal region of its stem.
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	30 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients whose medical condition is Osteoarthritis of the hip or Osteonecrosis of the femoral head and are in need of primary total hip arthroplasty.
Key exclusion criteria	Patients who did not or could not take the tests required for this study.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Naomi Middle name Last name Kobayashi
Organization	Yokohama City University Medical Center
Division name	Orthopaedics
Zip code	2320024
Address	4-57 Urafune-cho, Minami-ku, Yokohama, Japan
TEL	045-261-5656
Email	naomik58@aol.com

Public contact
Name of contact person	1st name Naomi Middle name Last name Kobayashi
Organization	Yokohama City University Medical Center
Division name	Orthopaedics
Zip code	232-0024
Address	4-57 Urafune-cho, Minami-ku, Yokohama, Japan
TEL	045-261-5656
Homepage URL
Email	naomik58@aol.com

Sponsor
Institute	Yokohama City University Orthopaedics
Institute
Department

Funding Source
Organization	Yokohama City University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Clinical Research Coordination Department, Center for Novel and Exploratory Clinical Trials
Address	3-9 Fukuura Kanazawa-ku, Yokohama Japan
Tel	045-787-2714
Email	nextjim1@yokohama-cu.ac.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	2016 Year 07 Month 13 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	53
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	2015 Year 03 Month 18 Day
Date of IRB	2015 Year 04 Month 01 Day
Anticipated trial start date	2015 Year 03 Month 18 Day
Last follow-up date	2020 Year 01 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 07 Month 13 Day
Last modified on	2020 Year 01 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026560