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

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 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

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

Value
https://center6.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