UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023595 |
|---|---|
| Receipt number | R000027152 |
| Scientific Title | Locomotive syndrome; The intervention effect of operation and economic indicator (multicenter prospective observational study) |
| Date of disclosure of the study information | 2016/08/20 |
| Last modified on | 2018/11/19 10:01:48 |
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Basic information
Public title
Locomotive syndrome; The intervention effect of operation and economic indicator (multicenter prospective observational study)
Acronym
Locomotive syndrome; The intervention effect of operation and economic indicator
Scientific Title
Locomotive syndrome; The intervention effect of operation and economic indicator (multicenter prospective observational study)
Scientific Title:Acronym
Locomotive syndrome; The intervention effect of operation and economic indicator
Region
| Japan |
Condition
Condition
Lumbar spinal canal stenosis
Osteoarthritis of the knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify
-the impact of operations for lumbar decompression and total knee arthroplasty on the locomotive function and the medical economic effect
-influence of the age on the effect
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaires on physical activity (GLFS-25), QOL questionnaire (EQ-5D-5L), and the data of health insurance claims. Preoperation and 1 year after operation.
Key secondary outcomes
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
| 60 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Lumbar spinal canal stenosis
1) elective decompression without instrumentations
2) patients who we can do one-year follow-up study
Osteoarthritis of the knee
1) elective total knee arthroplasty
2) patients who we can do one-year follow-up study
Key exclusion criteria
1) patients who have severe complications
2) cases of the second surgery
3) patients who have locomotory surgical histories or fracture treatment within a year
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tanaka, Sakae |
Organization
Faculty of Medicine, The University of Tokyo
Division name
Department of Orthopaedic Surgery
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.
TEL
03-3815-5411
tanakas-ort@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chikuda, Hirotaka |
Organization
Faculty of Medicine, The University of Tokyo
Division name
Department of Orthopaedic Surgery
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.
TEL
03-3815-5411
Homepage URL
chikuda-tky@umin.ac.jp
Sponsor or person
Institute
Faculty of Medicine, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
The Japanese Orthopaedic Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Rehabilitation Center for Persons with Disabilities
Department of Health Care Economics and Industrial Policy, Osaka University Graduate School of Medicine
Department of Orthopaedic Surgery, Faculty of Medicine, The University of Ehime
Department of Orthopaedic Surgery, Faculty of Medicine, The University of Hirosaki
Department of Orthopaedic Surgery, Faculty of Medicine, The University of Kyoto
Department of Orthopedic Biomaterial Science, Osaka University Graduate School of Medicine
Department of Orthopaedic Surgery, Faculty of Medicine, The University of Kyusyu
Department of Orthopaedic Surgery, Faculty of Medicine, The University of Toyama
Department of Orthopaedic Surgery, Faculty of Medicine, The University of Akita
Department of Orthopaedic Surgery, Tokyo Medical and Dental University
Department of Orthopaedic Surgery, Japanese Red Cross Medical Center
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
| 2016 | Year | 08 | Month | 20 | 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
| 2016 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | 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
This study is aiming to reveal the effectiveness of operative intervention to lumbar canal stenosis and osteoarthritis of the knee, major diseases of locomotive syndrome. Health economical assessment will be also performed.
Management information
Registered date
| 2016 | Year | 08 | Month | 11 | Day |
Last modified on
| 2018 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027152
