UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018546 |
|---|---|
| Receipt number | R000021451 |
| Scientific Title | The comparison study between the healthy persons in middle ages and elderly about lower extremity function and physical activity after total hip arthroplasty(THA) at 10-years. |
| Date of disclosure of the study information | 2015/08/05 |
| Last modified on | 2016/06/28 11:29:46 |
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Basic information
Public title
The comparison study between the healthy persons in middle ages and elderly about lower extremity function and physical activity after total hip arthroplasty(THA) at 10-years.
Acronym
The comparison between healthy persons in middle ages and elderly about lower extremity function.
Scientific Title
The comparison study between the healthy persons in middle ages and elderly about lower extremity function and physical activity after total hip arthroplasty(THA) at 10-years.
Scientific Title:Acronym
The comparison between healthy persons in middle ages and elderly about lower extremity function.
Region
| Japan |
Condition
Condition
Hip osteoarthritis
The healthy persons in middle ages and elderly
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare patients after THA at 10-years with the healthy persons in middle ages and eldery about lower extremity function and physical activity
And consider the necessity of continued intervention to patients after THA at 10-years
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Hip abductor muscle strength
Key secondary outcomes
Physical activity
(International Physical Activity Questionnaire(IPAQ))
5-m timed gait test
One leg standing test
Lower limb circumferences
Timed up and Go (TUG) test
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients after THA at 10-years
2)The healthy persons in middle ages and ellderly
Key exclusion criteria
1)Persons with past surgical history
2)Persons with progressive disorder of the nervous system and muscle
3)Persons scheduled for arthroplasy with osteotomy
4)Persons scheduled for arthroplasy with hip adductor muscle dehiscence
5)Persons with dementia
6)Persons with the depression or schizophrenic disorder
7)Persons with cerebro-vascular disease
8)Persons with untreated cardio-vascular disorder
Target sample size
111
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Hirakawa |
Organization
Shonan Kamakura Joint Reconstruction Center
Division name
Department of Orthopaedic Surgery
Zip code
Address
5-4-17 Dai, Kamakura, Kanagawa, Japan
TEL
0467-47-2377
mail@skjrc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Suzuki |
Organization
Shonan Kamakura Joint Reconstruction Center
Division name
Department of Rehabilitation
Zip code
Address
5-4-17 Dai, Kamakura, Kanagawa, Japan
TEL
0467-47-2377
Homepage URL
reha@skjrc.jp
Sponsor or person
Institute
Shonan Kamakura Joint Reconstruction Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokushukai Kamakura Gymnastics Club
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
医療法人沖縄徳洲会 湘南鎌倉人工関節センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 05 | 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
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Influential factor: aging and THA.
Outcome : lower extremity function and physical activity.
Prospective stdy.
Management information
Registered date
| 2015 | Year | 08 | Month | 05 | Day |
Last modified on
| 2016 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021451
