UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040374 |
|---|---|
| Receipt number | R000046068 |
| 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- |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2020/08/26 20:34:38 |
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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
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
mail@skjrc.jp
Sponsor or person
Institute
Shonan Kamakura Joint Reconstruction Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046068
| 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 |
