UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008454 |
|---|---|
| Receipt number | R000009944 |
| Scientific Title | Postoperative activities of daily living,function of lower lims and mental status after total knee arthroplasty |
| Date of disclosure of the study information | 2012/07/25 |
| Last modified on | 2018/01/20 09:47:42 |
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Basic information
Public title
Postoperative activities of daily living,function of lower lims and mental status after total knee arthroplasty
Acronym
Postoperative activities of daily living
Scientific Title
Postoperative activities of daily living,function of lower lims and mental status after total knee arthroplasty
Scientific Title:Acronym
Postoperative activities of daily living
Region
| Japan |
Condition
Condition
Osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate ADL after TKA
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Timed up and go test
Timed one foot standing test
Zung self-rating depression scale
Key secondary outcomes
Pain of Visual Analog Scale(100mm)
X-ray
Japanese Knee Osteoarthritis Measure(JKOM)
Japanese Orthopaedic Association knee score(JOA score)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Total knee arthroplasty
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who had total knee arthroplasty in this hospital
Key exclusion criteria
Revision total knee arthroplasty
Previous history of infection
A patient with a trauma
A patient with a neuromuscular disease
A patient with a Dementia
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuu Sugawara |
Organization
Juntendo Tokyo Koto Geriatric Medical Center
Division name
Orthopaedics
Zip code
Address
3-3-20 sinsuna kotoku tokyo Japan
TEL
03-5632-3111
sugayu-@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuu Sugawara |
Organization
Juntendo Tokyo Koto Geriatric Medical Center
Division name
Orthopaedics
Zip code
Address
3-3-20 sinsuna kotoku tokyo Japan
TEL
03-5632-3111
Homepage URL
sugayu-@juntendo.ac.jp
Sponsor or person
Institute
Juntendo Tokyo Koto Geriatric Medical Center
Institute
Department
Personal name
Funding Source
Organization
Juntendo Tokyo Koto Geriatric Medical Center
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
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 17 | Day |
Last modified on
| 2018 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009944
