UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	XLIF versus OLIF for Lumbar Spinal Stenosis - a Randomized Clinical Trial-
Title of the study (Brief title)	XLIF versus OLIF - a Randomized Trial-
Region	Japan

Condition
Condition	Lumbar Spinal Stenosis with Degenerative Deformity or Intervertebral Instability
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the surgical results, especially complication, between eXtreme Lateral Interbody Fusion (XLIF) and Oblique Lateral Interbody Fusion (OLIF) in a randomized clinical trial.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Surgical Complications at 1 week 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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	eXtreme Lateral Interbody Fusion
Interventions/Control_2	Oblique Lateral Interbody Fusion
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	1 or 2 level lumbar spinal stenosis patients suffering from severe CLBP and/or leg pain resulting from lumbar spinal deformity, such as spondylolisthesis or degenerative spinal scoliosis, or lumbar segmental instability.
Key exclusion criteria	1) malignancy or spinal infection 2) dementia or disturbance of consciousness 3) anatomical abnormality in perivertebral organs (major vessels, kidney, ureter, psoas muscle, neural plexus) 4) vertebral fracture
Target sample size	100

Research contact person
Name of lead principal investigator	Masatoshi Hoshino
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Orthopaedic Surgery
Address	1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL	06-6645-3851
Email	hoshino717@gmail.com

Public contact
Name of contact person	Masatoshi Hoshino
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Orthopaedic Surgery
Address	1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL	06-6645-3851
Homepage URL
Email	hoshino717@gmail.com

Sponsor
Institute	Department of Orthopaedic Surgery, Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Orthopaedic Surgery, Osaka City University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 31 Day
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 07 Month 18 Day
Last modified on	2019 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021236