UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034229
Receipt number R000039010
Scientific Title Retrospective study to evaluate reduction effect and safety of lumbar interbody fusion using percutaneous endoscopy via retroperitoneal space for lumbar instability
Date of disclosure of the study information 2018/09/22
Last modified on 2019/09/24 19:32:00

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Basic information

Public title

Retrospective study to evaluate reduction effect and safety of lumbar interbody fusion using percutaneous endoscopy via retroperitoneal space for lumbar instability

Acronym

Retrospective study to evaluate reduction effect and safety in KyoLIF

Scientific Title

Retrospective study to evaluate reduction effect and safety of lumbar interbody fusion using percutaneous endoscopy via retroperitoneal space for lumbar instability

Scientific Title:Acronym

Retrospective study to evaluate reduction effect and safety in KyoLIF

Region

Japan


Condition

Condition

Lumbar instability, Degenerative spondylolisthesis, Isthmic spondylolisthesis, Lumbar spinal canal stenosis, Lumbar foraminal stenosis, Lumbar degenerative scoliosis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate safety of percutaneous endoscopic anterior lumbar interbody fusion.
To evaluate reduction effect of percutaneous endoscopic anterior lumbar interbody fusion.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

peri- and postoperative complications

Key secondary outcomes

disc space height, foraminal height, sagittal rotation angle, whole lumbar lordosis, sagittal translation distance,
clinical course


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

90 years-old >

Gender

Male and Female

Key inclusion criteria

Surgery:Percutaneous endoscopic lumbar interbody fusion
Approach:Via retroperitoneal space
Period:Performed from February 2017

Key exclusion criteria

Patients who underwent PLIF for other level at same time

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshinori Kyoh

Organization

Kyoh Orthopaedics & Neurosurgery Clinic

Division name

Orthopaedics

Zip code


Address

54 Misono-cho, Amagasaki-city, Hyogo, Japan

TEL

81(6)6411-0714

Email

yhkang@kyoh-clinic.com


Public contact

Name of contact person

1st name
Middle name
Last name Yoshinori Kyoh

Organization

Kyoh Orthopaedics & Neurosurgery Clinic

Division name

Orthopaedics

Zip code


Address

54 Misono-cho, Amagasaki-city, Hyogo, Japan

TEL

81(6)6411-0714

Homepage URL


Email

yhkang@kyoh-clinic.com


Sponsor or person

Institute

Kyoh Orthopaedics & Neurosurgery Clinic

Institute

Department

Personal name



Funding Source

Organization

none

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

きょう整形外科・神経外科クリニック(兵庫県)


Other administrative information

Date of disclosure of the study information

2018 Year 09 Month 22 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

The 17th PASMISS
The 24th JPSTSS
The 26th JSIS
KOMISS International Symposium
The 21st Kansai MISt
The 47th JSSR
The Leon Wiltse Spine Symposium (Invited Lecture)
The 2nd ISESS/ The 2nd ISMISS Asia Japan/The 11th MISS Summit Forum (Invited Lecture)
The 21st JASMISS
The 7th ACMISST & 18th KOMISS (Best Oral Presentation Award 3rd Place)
The 12th MISS Summit Forum (Live Surgery & Invited Lecture)

Neurospine 2019;16(1):72-81)

Results date posted

2019 Year 09 Month 24 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2019 Year 03 Month 31 Day

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

2017 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2017 Year 02 Month 15 Day

Last follow-up date

2019 Year 10 Month 31 Day

Date of closure to data entry

2019 Year 10 Month 31 Day

Date trial data considered complete

2020 Year 01 Month 31 Day

Date analysis concluded

2020 Year 02 Month 01 Day


Other

Other related information

None


Management information

Registered date

2018 Year 09 Month 21 Day

Last modified on

2019 Year 09 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039010


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name