UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044699 |
|---|---|
| Receipt number | R000051053 |
| Scientific Title | APSS multicenter study regarding brace treatment for AIS patients. |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2024/01/02 21:21:39 |
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Basic information
Public title
APSS collaborative study Comparison of success rate of brace treatment by different bone maturity assessment methods
Acronym
deterioration after brace treatment for AIS patients
Scientific Title
APSS multicenter study regarding brace treatment for AIS patients.
Scientific Title:Acronym
APSS multicenter study regarding brace treatment for AIS patients.
Region
| Japan | Asia(except Japan) |
Condition
Condition
The AIS patients with brace treatment
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Which skeletal evaluation, such as Risser sign, Sander's classification and DRU classification, menarche, age, height growth just before brace off (cm/month), relate to curve progression after brace off?
Basic objectives2
Others
Basic objectives -Others
The curve progression rate after brace weaning within two years
Which curve type related to curve progression after brace off?
The success rate of brace treatment among various types of brace in Asian countries
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Sex
2.Age(**y and **months) (initial, the time when the brace finish)
3.height, body weight, arm spam, sitting height
4.Risser sign (initial, the time when the brace finish), Sander's classification
5.DRU classification (left hand X-ray initially and the time when the brace finish)
6.Sanders classification
7.Menarche
8.once-off weaning or stepwise weaning.
9.Brace type ( Under arm brace yes/no, )
Key secondary outcomes
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
AIS patients with brace treatment
Key exclusion criteria
Patients with congenital or neuromuscular scoliosis.
Patients with early onset scoliosis ( less than 10 yrs olds.)
Patients with brace less than 12 hours during brace treatment based on patient's and parent's report.
Basically please recommend wearing brace more than 20 hours.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Sakai |
Organization
Tokai University
Division name
Orthopaedic 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 | |
| Last name | Shigematsu |
Organization
Nara Medical University
Division name
Orthopaedic surgery
Zip code
6348522
Address
840 Shijocho Kashihara city Nara
TEL
0744-22-3051
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
Asia Pacific spine society
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 Brace type, Time of wearing brace
Management information
Registered date
| 2021 | Year | 06 | Month | 29 | Day |
Last modified on
| 2024 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051053
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
