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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023595
Receipt No. 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

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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
Email 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
Email chikuda-tky@umin.ac.jp

Sponsor
Institute Faculty of Medicine, The University of Tokyo
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027152

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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