UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028710
Receipt number R000032858
Scientific Title The research of QOL in patients with cervical malalignment and cervical spondylotic myelopathy using questionnaire incorporating patients
Date of disclosure of the study information 2017/09/01
Last modified on 2023/08/22 20:47:29

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Basic information

Public title

The research of QOL in patients with cervical malalignment and cervical spondylotic myelopathy using questionnaire incorporating patients

Acronym

QOL in patients with The research of QOL in patients with cervical disease

Scientific Title

The research of QOL in patients with cervical malalignment and cervical spondylotic myelopathy using questionnaire incorporating patients

Scientific Title:Acronym

QOL in patients with The research of QOL in patients with cervical disease

Region

Japan


Condition

Condition

Cervical malalignment and cervical spondylotic myelopathy

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate outcome of conservative or surgical treatment using questionnaire incorporating patients

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

NDI
JOA score
History of sports activity
History of occupation

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

18 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

The patients with cervical malalignment or cervical spondylotic myelopathy who visit our hospital

Key exclusion criteria

The case which consent was not obtained from the patients or their family

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name Shin
Middle name
Last name Oe

Organization

Hamamatsu University School of Medicine

Division name

Geriatric Musculoskeletal Health

Zip code

4313192

Address

1-20-1 Handayama, Higashi-ku, Hamamatu city, Shizuoka, Japan

TEL

053-435-2299

Email

mecersior@gmail.com


Public contact

Name of contact person

1st name Shin
Middle name
Last name Oe

Organization

Hamamatsu university School of Medicine

Division name

Division of Musculoskeletal Health

Zip code

4313192

Address

1-20-1 Handayama, Higashi-ku, Hamamatu city, Shizuoka, Japan

TEL

053-435-2299

Homepage URL


Email

mecersior@gmail.com


Sponsor or person

Institute

Hamamatsu University School of Medicine, Division of Mucsuloskeletal Health

Institute

Department

Personal name



Funding Source

Organization

Hamamatsu University School of Medicine, Division of Mucsuloskeletal Health

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Department of Institutional Review Board, Hamamatsu University School of Medicine

Address

1-20-1 Handayama, Higashi ward, Hamamatsu city , Shizuoka

Tel

0534352299

Email

mecersior@gmail.com


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

浜松医科大学付属病院(静岡県)


Other administrative information

Date of disclosure of the study information

2017 Year 09 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

Under evaluation

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

Open public recruiting

Date of protocol fixation

2017 Year 08 Month 04 Day

Date of IRB

2017 Year 08 Month 01 Day

Anticipated trial start date

2017 Year 08 Month 04 Day

Last follow-up date

2027 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Nothing


Management information

Registered date

2017 Year 08 Month 17 Day

Last modified on

2023 Year 08 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032858


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name