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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001968
Receipt No. 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

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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
Email

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
Email w-tk@umin.ac.jp

Sponsor
Institute The University of Tokushima Graduate School, Institute of Health Biosciences
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002398

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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