UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023048 |
|---|---|
| Receipt number | R000026566 |
| Scientific Title | Retrospective observational study to predict functional outcome of total hip arthroplasty(THA) |
| Date of disclosure of the study information | 2016/07/07 |
| Last modified on | 2016/07/07 01:37:06 |
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Basic information
Public title
Retrospective observational study to predict functional outcome of total hip arthroplasty(THA)
Acronym
Retrospective observational study to predict functional outcome of total hip arthroplasty(THA)
Scientific Title
Retrospective observational study to predict functional outcome of total hip arthroplasty(THA)
Scientific Title:Acronym
Retrospective observational study to predict functional outcome of total hip arthroplasty(THA)
Region
| Japan |
Condition
Condition
Hip osteoarthritis patients who underwent a primary THA
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the factor that influence the functional outcome of total hip arthroplasty
Basic objectives2
Others
Basic objectives -Others
To investigate the factor that influence the functional outcome of total hip arthroplasty
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical function:Japanese Orthopedic Association Hip Disease Evaluation Questionnaire(JHEQ)/Movement sub score
Key secondary outcomes
Motor function:Range of motion(ROM),Hip abductor and knee extensor strength
Ambulatory ability:Timed "Up & Go" test(TUG)
Quality of Life(QOL):JHEQ
Psychological state:JHEQ/Mental sub score,modified Gait Efficacy Scale(mGES)
Physical activity:Life Space Assessment(LSA)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Primary THA patients who completed follow-up for 6 months postoperatively.
Key exclusion criteria
Rheumatoid arthritis
Osteonecrosis of femoral head
Revision THA
Neurological disorder
Cognitive impairment
Missing data
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Kugo |
Organization
Shiga University of Medical Science Hospital
Division name
Rehabilitation Units
Zip code
Address
Seta Tsukinowa-cho,Otsu,Shiga
TEL
077-548-2670
9563@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masato Kugo |
Organization
Shiga University of Medical Science Hospital
Division name
Rehabilitation Units
Zip code
Address
Seta Tsukinowa-cho,Otsu,Shiga
TEL
077-548-2670
Homepage URL
9563@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science 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
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
滋賀医科大学医学部附属病院（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 07 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | 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
A total of 233 patients underwent THA at the Department of Orthopedic Surgery in Shiga University of Medical Science Hospital between April 2013 and March
2016.The study participants who met the inclusion and exclusion criteria were approximately 100 patients.
Management information
Registered date
| 2016 | Year | 07 | Month | 07 | Day |
Last modified on
| 2016 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026566
| 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 |
