UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044688 |
|---|---|
| Receipt number | 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 18:21:06 |
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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
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
shideki@naramed-u.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051044
