UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018916 |
|---|---|
| Receipt number | R000021886 |
| Scientific Title | Retrospective observational study |
| Date of disclosure of the study information | 2015/09/06 |
| Last modified on | 2019/12/23 16:22:09 |
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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
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/
koseki@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021886
| 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 |
