UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017462
Receipt number R000020240
Scientific Title Surgical treatment of thoracic adolescent idiopathic scoliosis with maintenance of kyphosis
Date of disclosure of the study information 2015/05/08
Last modified on 2015/05/08 14:41:59

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Basic information

Public title

Surgical treatment of thoracic adolescent idiopathic scoliosis with maintenance of kyphosis

Acronym

Surgical treatment of thoracic adolescent idiopathic scoliosis

Scientific Title

Surgical treatment of thoracic adolescent idiopathic scoliosis with maintenance of kyphosis

Scientific Title:Acronym

Surgical treatment of thoracic adolescent idiopathic scoliosis

Region

Japan


Condition

Condition

adolescent idiopathic scoliosis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the surgical outcomes of the simultaneous double-rod rotation technique for treating Lenke 1 thoracic adolescent idiopathic scoliosis

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

patient demographics, radiographic measurements, and Scoliosis Research Society questionnaire scores

Key secondary outcomes



Base

Study type


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

surgical treatment

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

10 years-old <=

Age-upper limit

20 years-old >=

Gender

Male and Female

Key inclusion criteria

thoracic adolescent idiopathic scoliosis

Key exclusion criteria

syndromic, neuromuscular, and congenital scoliosis and the presence of other thoracic scoliosis curves such as double thoracic curves

Target sample size

32


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hideki Sudo

Organization

Hokkaido University Hospital

Division name

Department of Orthopaedic Surgery

Zip code


Address

North-15, West-7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan

TEL

011-706-5934

Email

hidekisudo@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hideki Sudo

Organization

Hokkaido University Hospital

Division name

Department of Orthopaedic Surgery

Zip code


Address

North-15, West-7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan

TEL

011-706-5934

Homepage URL


Email

hidekisudo@yahoo.co.jp


Sponsor or person

Institute

Hokkaido University Hospital

Institute

Department

Personal name



Funding Source

Organization

Hokkaido University Hospital

Organization

Division

Category of Funding Organization

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

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

2015 Year 05 Month 08 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2015 Year 02 Month 06 Day

Date of IRB


Anticipated trial start date

2015 Year 02 Month 06 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 05 Month 08 Day

Last modified on

2015 Year 05 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020240


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name