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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044688
Receipt No. R000051044
Scientific Title APSS collaborative study: multicenter validation of the distal radius and ulna classification
Date of disclosure of the study information 2021/07/01
Last modified on 2021/06/28

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Basic information
Public title Validity study for bone maturity using with hand X-ray
Acronym DRU validity study
Scientific Title APSS collaborative study: multicenter validation of the distal radius and ulna classification
Scientific Title:Acronym APSS collaborative study: multicenter validation of the distal radius and ulna classification
Region
Japan Asia(except Japan)

Condition
Condition Adolescent idiopathic scoliosis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This multi-center study has two aims,
1) to investigate which degree of the DRU classification can predict PHV

Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationship between DRU classification and PHV
Key secondary outcomes Relationship between DRU classification and curve progressions
Relationship between initial Cobb angle and scoliosis progression in each of the DRU classifications.
Country Differences in Risk Factors for curve progression.

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
5 years-old <=
Age-upper limit
18 years-old >=
Gender Male and Female
Key inclusion criteria Adolescent idiopathic scoliosis
Key exclusion criteria congenital scoliosis
syndromic scoliosis
Target sample size 350

Research contact person
Name of lead principal investigator
1st name Daisuke
Middle name
Last name Sakai
Organization Tokai University
Division name Orhthopaedic surgery
Zip code 259 -1193
Address 143 Isehara city Kanagawa
TEL 0463-93-1121
Email daisakai@is.icc.u-tokai.ac.jp

Public contact
Name of contact person
1st name Hideki
Middle name Shigematsu
Last name Shigematsu
Organization Nara Medical University
Division name Orthopaedic surgery
Zip code 634-8522
Address 840 Shijocho Kashihara city Nara
TEL 0744223051
Homepage URL
Email shideki@naramed-u.ac.jp

Sponsor
Institute Tokai University
Institute
Department

Funding Source
Organization self management
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 Tokai University
Address 143 Isehara city Kanagawa
Tel 0463 93 1121
Email daisakai@is.icc.u-tokai.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
2021 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 Enrolling by invitation
Date of protocol fixation
2021 Year 01 Month 01 Day
Date of IRB
2020 Year 07 Month 21 Day
Anticipated trial start date
2021 Year 01 Month 01 Day
Last follow-up date
2034 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Joined 11 institutions in Japan.
We are collecting data regarding skeletal maturity such as Age, Risser grade, DRU classification and Sanders classification on Hand X-ray, menarche, height, weight, arm spam, sitting height.

Management information
Registered date
2021 Year 06 Month 28 Day
Last modified on
2021 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051044

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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