UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035455
Receipt number R000040394
Scientific Title Randomized non-inferiority test of reduced implant laminoplasty.
Date of disclosure of the study information 2019/02/01
Last modified on 2022/01/12 11:29:43

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Basic information

Public title

Randomized non-inferiority test of reduced implant laminoplasty.

Acronym

SKIP-2

Scientific Title

Randomized non-inferiority test of reduced implant laminoplasty.

Scientific Title:Acronym

SKIP-2

Region

Japan


Condition

Condition

cervical spodylotic myelopathy

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the non-inferiority of implant reduced laminoplasty compare to the standard one.

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

cervical JOA score 2 years postoperatively

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Tha group undergo the laminoplasty with four implants

Interventions/Control_2

Tha group undergo the laminoplasty with teo implants

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

60 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Patients who will undergo lamioplasty for cervical spondylotic myelopathy in the Osaka City Unviversity Hospital or related instituion
2. Patients who will undergo lamioplasty from C3-C6
3. Patients who is equal or more than 60 years old
4. Patients with agreement after provided informed consent

Key exclusion criteria

1. Patients with severe cervical kyphosis
2. Patients with severe cervical instabilitiy
3. Patients with history of previous cervical surgery
4. Patient with severe OPLL
5. Patient with severe renal disease
6. Patient with severe liver disease

Target sample size

160


Research contact person

Name of lead principal investigator

1st name Akinobu
Middle name
Last name Suzuki

Organization

Osaka City University

Division name

Orthopedics

Zip code

545-8585

Address

Asahimachi

TEL

0666453851

Email

koji.tamai@msic.med.osaka-cu.ac.jp


Public contact

Name of contact person

1st name Koji
Middle name
Last name Tamai

Organization

Osaka City University

Division name

Orthopedics

Zip code

545-8585

Address

Asahimachi

TEL

0666453851

Homepage URL


Email

koji.tamai@msic.med.osaka-cu.ac.jp


Sponsor or person

Institute

Osaka City University

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

IRB of Osaka City Univeristy

Address

Asahimachi

Tel

+81666453851

Email

ethics@med.osaka-cu.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

4170

Org. issuing International ID_1

Osaka City University Hospital Certified Review Board

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2019 Year 02 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

No longer recruiting

Date of protocol fixation

2018 Year 11 Month 22 Day

Date of IRB

2018 Year 11 Month 22 Day

Anticipated trial start date

2019 Year 02 Month 01 Day

Last follow-up date

2024 Year 02 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 01 Month 05 Day

Last modified on

2022 Year 01 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040394


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name