UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001968 |
|---|---|
| Receipt number | R000002398 |
| Scientific Title | Factors that determine the muscle adaptation during limb lengthening |
| Date of disclosure of the study information | 2009/05/14 |
| Last modified on | 2014/11/13 21:53:04 |
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Basic information
Public title
Factors that determine the muscle adaptation during limb lengthening
Acronym
Factors that determine the muscle adaptation during limb lengthening
Scientific Title
Factors that determine the muscle adaptation during limb lengthening
Scientific Title:Acronym
Factors that determine the muscle adaptation during limb lengthening
Region
| Japan |
Condition
Condition
Limb shortening
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the factors that affect the muscle adaptation during limb lengthening
Basic objectives2
Others
Basic objectives -Others
Restriction of the joint motion and loss of muscle strength are thought to be caused by insufficiency of the muscle adaptation. Therefore, we should clarify the cause of the insufficiency.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Genes that are related with msucle regeneration and repair in skeletal muscles
Key secondary outcomes
Joint range of motion and muscle strength
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Gene |
Interventions/Control_1
limb lengthening
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
| 10 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have shortening of the limb
Key exclusion criteria
person who has already had muscle injury on the segment that is subject to be lengthened
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiko Takahashi |
Organization
The University of Tokushima Graduate School, Institute of Health Biosciences
Division name
Department of Orthopaedics
Zip code
Address
3-18-15 Kuramoto Tokushima
TEL
088-633-7240
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuhiko Takahashi |
Organization
The University of Tokushima Graduate School, Institute of Health Biosciences
Division name
Department of Orthopaedics
Zip code
Address
3-18-15 Kuramoto Tokushima
TEL
088-633-7240
Homepage URL
w-tk@umin.ac.jp
Sponsor or person
Institute
The University of Tokushima Graduate School, Institute of Health Biosciences
Institute
Department
Personal name
Funding Source
Organization
The University of Tokushima Graduate School, Institute of Health Biosciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
| 2009 | Year | 05 | Month | 14 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 05 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 05 | Month | 13 | Day |
Last modified on
| 2014 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002398
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