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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018916
Receipt No. R000021886
Scientific Title Retrospective observational study
Date of disclosure of the study information 2015/09/06
Last modified on 2019/12/23

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Basic information
Public title Clinical studies of the osteotomy for osteoarthritis of knee
Acronym Clinical outcome study of the tibial condyle valgus osteotomy
Scientific Title Retrospective observational study
Scientific Title:Acronym Observational study
Region
Japan

Condition
Condition gonarthrosis
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We analyze the tibial condyle valgus osteotomy from a multidirectional viewpoint, and clarify the mechanisms, effects, indications, and complications of the surgery method.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Image study findings (CT, MRI, simple X-rays) and rehabilitation information (Muscular strength, range of motion, walk, ADL) at 6 months, 1 year, and 2 years after surgery.
Key secondary outcomes JOA score, KOOS score, VAS, %MA, movement analysis

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 High tibial osteotomy
Interventions/Control_2 Tibial condyle valgus osteotomy
Interventions/Control_3 High tibial osteotomy+Tibial condyle valgus osteotomy
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients who were indicated osteotomy surgery
Key exclusion criteria The case that can not follow up
Target sample size 41

Research contact person
Name of lead principal investigator
1st name HIRONOBU
Middle name
Last name KOSEKI
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Locomotive Rehabilitation Science
Zip code 852-8520
Address 1-7-1, Sakamoto, Nagasaki 852-8501, Japan
TEL +81958197321
Email koseki@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name Hironobu
Middle name
Last name Koseki
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Locomotive Rehabilitation Science, Unit of Rehabilitation sciences
Zip code 852-8520
Address 1-7-1, Sakamoto, Nagasaki 852-8501, Japan
TEL +81-95-819-7321
Homepage URL http://www.mdp.nagasaki-u.ac.jp/
Email koseki@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

Funding Source
Organization KAKENHI 15K01372
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The research ethics committee at Nagasaki University
Address 1-7-1, Sakamoto
Tel +81958197321
Email koseki@nagasaki-u.ac.jp

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
2015 Year 09 Month 06 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 64
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 09 Month 05 Day
Date of IRB
2015 Year 08 Month 25 Day
Anticipated trial start date
2015 Year 09 Month 06 Day
Last follow-up date
2019 Year 11 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 09 Month 05 Day
Last modified on
2019 Year 12 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021886

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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