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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000022967
Receipt No. R000026474
Scientific Title Analysis of bone fracture healing by using high-resolution peripheral quantitative CT (HR-pQCT)
Date of disclosure of the study information 2016/07/01
Last modified on 2016/07/01

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Basic information
Public title Analysis of bone fracture healing by using high-resolution peripheral quantitative CT (HR-pQCT)
Acronym Analysis of bone fracture healing by using HR-pQCT
Scientific Title Analysis of bone fracture healing by using high-resolution peripheral quantitative CT (HR-pQCT)
Scientific Title:Acronym Analysis of bone fracture healing by using HR-pQCT
Region
Japan

Condition
Condition Distal radius fracture or scaphoid fracture
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigating the mechanism of fracture healing in the longitudinal analysis of hand and forearm fractures by using HR-pQCT
Basic objectives2 Others
Basic objectives -Others Analysis of the change of bone microstructure and bone strength in the process of bone healing
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Bone mineral density of the fracture region at 1, 4, 8, 12, 16, 20, and 24 weeks after injury
Key secondary outcomes Trabecular bone microstructure, cortical bone microstructure, and estimated bone strength at 1, 4, 8, 12, 16, 20, and 24 weeks after injury

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) The patients with distal radius fracture or scaphoid fracture
2) A written informed consent for the participation in the study
Key exclusion criteria 1) The patients with the past history of the same part fracture
2) Patients with metabolic diseases which may affect to the bone metabolism (e.g.,rheumatoid arthritis)
3) Patients treated with medication which affect to the bone metabolism (e.g., glucocorticosteroids)
4) Patients judged to be inadequate for this study by investigators
Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ko Chiba
Organization Nagasaki University Hospital
Division name Department of orthopaedic surgery
Zip code
Address 1-7-1 Sakamoto, Nagasaki city, Nagasaki prefecture, Japan
TEL 095-819-7321
Email kohchiba@estate.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ko Chiba
Organization Nagasaki University Hospital
Division name Department of orthopaedic surgery
Zip code
Address 1-7-1 Sakamoto, Nagasaki city, Nagasaki prefecture, Japan
TEL 095-819-7321
Homepage URL
Email kohchiba@estate.ocn.ne.jp

Sponsor
Institute Nagasaki University Hospital
Institute
Department

Funding Source
Organization Department of orthopaedic surgery, Nagaski University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 16031418
Org. issuing International ID_1 Clinical reserch, Nagasaki University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 長崎大学病院(長崎県)/ Nagasaki University Hospital (Nagasaki prefecture)

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 01 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
Date of protocol fixation
2016 Year 03 Month 02 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study

The patients with distal radius fracture or scaphoid fracture who consult Nagasaki university hospital after Mach 2016 and who is eligible for the inclusion criteria

Management information
Registered date
2016 Year 07 Month 01 Day
Last modified on
2016 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026474

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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