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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034229
Receipt No. 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 2018/09/21

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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
Institute Kyoh Orthopaedics & Neurosurgery Clinic
Institute
Department

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 Annual Meeting of the Pacific and Asian Society of Minimally Invasive Spine Surgery PASMISS 2017
The 24th Annual Meeting of the Japan Society for the Study of Surgical Technique for Spine and Spinal Nerves JPSTSS 2017
The 26th Annual Meeting of the Japanese Spinal Instrumentation Society 2017
2017 KOMISS International Symposium
The 21st Kansai branch meeting of society for Minimally Invasive spine Stabilization 2018
The 47th Annual Meeting of the Japanese Society for Spine Surgery and Related Research 2018
The Leon Wiltse Spine Symposium 2018
The 2nd ISESS and The 2nd ISMISS Asia Japan and The 11th MISS Summit Forum 2018
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 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
2018 Year 09 Month 21 Day


Link to view the page
URL(English) https://upload.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


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