UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022539 |
|---|---|
| Receipt number | R000025974 |
| Scientific Title | Relationship of femoral anteversion change and the hip abductor muscle strength in Total Hip Arthoroplasty. |
| Date of disclosure of the study information | 2016/05/30 |
| Last modified on | 2021/07/02 16:26:50 |
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Basic information
Public title
Relationship of femoral anteversion change and the hip abductor muscle strength in Total Hip Arthoroplasty.
Acronym
Relationship of femoral anteversion change and the hip abductor muscle in THA.
Scientific Title
Relationship of femoral anteversion change and the hip abductor muscle strength in Total Hip Arthoroplasty.
Scientific Title:Acronym
Relationship of femoral anteversion change and the hip abductor muscle in THA.
Region
| Japan |
Condition
Condition
Total Hip Arthoroplasty due to acetabular dysplasia and osteonecrosis of femoral head
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To consider the relevance of the femoral anteversion and hip abductor muscle strength was changed before and after the surgery in Total Hip Arthoroplasty.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
femoral anteversion
Hip abductor muscle strength
Key secondary outcomes
pain:VAS
Functional:Harris Hip Score,JOA,JHEQ
gait ability and balance:Limping and continuous walking distance, One Foot Standing time
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Osteoarthritis of the hip, acetabular dysplasia, those who have been diagnosed with avascular necrosis of the femoral head
For participation in this study those consent of free will was obtained, or those that do not deny the participation of research
Key exclusion criteria
muscle testing can not be performed
Not taken a CT at before and after surgery
Others, principal investigator has determined to be inappropriate as a research subject
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Yuri |
Organization
Hokkaido University Hospital
Division name
Department of Rehabilitation
Zip code
0608648
Address
Sapporo Kita 14 Nishi 5-chome,Hokkaido
TEL
0117065740
f09050717981@gmail.com
Public contact
Name of contact person
| 1st name | Fumiya |
| Middle name | |
| Last name | Kizawa |
Organization
Hokkaido University Hospital
Division name
Department of Rehabilitation
Zip code
0608648
Address
Sapporo Kita 14 Nishi 5-chome,Hokkaido
TEL
011-706-5740
Homepage URL
http://www.huhp.hokudai.ac.jp/
pt-kizawa2@huhp.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido university hospital
Institute
Department
Personal name
Funding Source
Organization
no
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
Hokkaido University Hospital Clinical Research Administration Center
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
Tel
011-706-7636
crjimu@huhp.hokudai.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
北海道大学病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 30 | 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
Date of protocol fixation
| 2016 | Year | 02 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
the first hip replacement surgery at the hospital orthopedic hospital, those who are physical therapy training by the Department of Rehabilitation between from the authorization date of two years.
Management information
Registered date
| 2016 | Year | 05 | Month | 30 | Day |
Last modified on
| 2021 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025974
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
