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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018348
Receipt No. R000021236
Scientific Title XLIF versus OLIF for Lumbar Spinal Stenosis - a Randomized Clinical Trial-
Date of disclosure of the study information 2015/08/01
Last modified on 2019/01/28

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Basic information
Public title XLIF versus OLIF for Lumbar Spinal Stenosis - a Randomized Clinical Trial-
Acronym XLIF versus OLIF - a Randomized Trial-
Scientific Title XLIF versus OLIF for Lumbar Spinal Stenosis - a Randomized Clinical Trial-
Scientific Title:Acronym 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
1st name
Middle name
Last name Masatoshi Hoshino
Organization Osaka City University Graduate School
of Medicine
Division name Department of Orthopaedic Surgery
Zip code
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
1st name
Middle name
Last name Masatoshi Hoshino
Organization Osaka City University Graduate School of Medicine
Division name Department of Orthopaedic Surgery
Zip code
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)

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

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

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2015 Year 07 Month 31 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000021236

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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