UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032338
Receipt number R000036873
Scientific Title Recovery Process in Patients with Cervical Laminoplasty
Date of disclosure of the study information 2018/07/01
Last modified on 2018/04/21 01:19:30

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Basic information

Public title

Recovery Process in Patients with Cervical Laminoplasty

Acronym

Recovery Process Using JOACMEQ

Scientific Title

Recovery Process in Patients with Cervical Laminoplasty

Scientific Title:Acronym

Recovery Process Using JOACMEQ

Region

Japan


Condition

Condition

Cervical spondylotic myelopathy

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Hypothesis is made that the tendency of recovery process using the conventional JOA score and JOACMEQ, a patient-based evaluation, are different. Our object is to investigate the functional recovery process with laminoplasty performed to CSM using JOACMEQ.

Basic objectives2

Others

Basic objectives -Others

Our object is to clarify the relationship between the image evaluation using Xp, MRI, etc. and the improvement of the function after the operation.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

For the same patient, JOACMEQ are scored at each time point before operation, 1 month, 3 months, 6 months, 1 year and 2 years after operation. And we consider trends of recovery for each domain.

Key secondary outcomes

From image evaluation before and after operation, factors influencing postoperative results will be examined.


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Cases of performed cervical laminoplasty for cervical spondylosis myelopathy

Key exclusion criteria

1. Under 19 years old cases
2. Cases in which the postoperative evaluations are missed at least one point during 2 years after the operation
3. Infection
4. Dialysis cases
5. Trauma cases

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hideki Shigematsu

Organization

Nara medical university

Division name

Orthopedic Surgery

Zip code


Address

840 Shijyo-cho, Kashihara shi, Nara Prefecture

TEL

0744-22-3051

Email

shideki@naramed-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hideki Shigematsu

Organization

Nara medical university

Division name

Orthopedic Surgery

Zip code


Address

840 Shijyo-cho, Kashihara shi, Nara Prefecture

TEL

0744-22-3051

Homepage URL


Email

shideki@naramed-u.ac.jp


Sponsor or person

Institute

Nara medical university
Orthopedic Surgery

Institute

Department

Personal name



Funding Source

Organization

Nara medical university
Orthopedic Surgery

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


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

奈良県立医科大学(奈良県)、香芝旭ヶ丘病院(奈良県)


Other administrative information

Date of disclosure of the study information

2018 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

Preinitiation

Date of protocol fixation

2018 Year 04 Month 24 Day

Date of IRB


Anticipated trial start date

2018 Year 07 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observational study to evaluate postoperative recovery process


Management information

Registered date

2018 Year 04 Month 21 Day

Last modified on

2018 Year 04 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036873


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name