UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023147 |
|---|---|
| Receipt number | R000026560 |
| Scientific Title | Comparison of bone remodeling between HA coated new implant and conventional implant using 18F-fluoride PET and DEXA |
| Date of disclosure of the study information | 2016/07/13 |
| Last modified on | 2020/01/17 11:01:35 |
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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
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
naomik58@aol.com
Sponsor or person
Institute
Yokohama City University Orthopaedics
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026560
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
