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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002786
Receipt No. R000003386
Scientific Title Comparative study of surgical technique for lumbar spinal canal stenosis. (spinous spritting laminectomy vs conventional laminectomy)
Date of disclosure of the study information 2009/11/20
Last modified on 2009/11/19

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Basic information
Public title Comparative study of surgical technique for lumbar spinal canal stenosis. (spinous spritting laminectomy vs conventional laminectomy)
Acronym Comparative study of surgical technique for lumbar spinal canal stenosis. (spinous spritting laminectomy vs conventional laminectomy)
Scientific Title Comparative study of surgical technique for lumbar spinal canal stenosis. (spinous spritting laminectomy vs conventional laminectomy)
Scientific Title:Acronym Comparative study of surgical technique for lumbar spinal canal stenosis. (spinous spritting laminectomy vs conventional laminectomy)
Region
Japan

Condition
Condition Lumbar spinal canal stenosis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Compare effectiveness of spinous process splitting laminectomy with conventional technique for surgical results and postoperative low back pain in the treatment of lumbar spinal canal stenosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Postoperative wound pain.
Low back pain
Key secondary outcomes JOA score, VAS, MRI finding, serum CRP and CPK concentration

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 alternative use of conventional technique or spinous process splitting technique for patinets with lumbar spinal canal stenosis who have surgical indication
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

Not applicable
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Presence of neurogenic claudication
2) Persistence of symptoms for more than six months in spite of conservative therapy.
3) Clinical symptoms and neurological signs in the lower limbs corresponding to the level of stenosis on magnetic resonance (MR) or myelograms.
4) Decompression necessary at a single level or two levels.
Key exclusion criteria 1)Spinal canal stenosis due to congenital, spondylolytic, traumatic and iatrogenic causes.
2) Any previous operation in the lumbar area.
3) The presence of other specific spinal disorders (e.g., ankylosing spondylitis, neoplasm, or metabolic diseases).
4) Intermittent claudication resulting from peripheral arterial disease.
5) Severe osteoarthrosis or arthritis in the lower limbs.
6) Neurologic disease causing impaired function of the lower limbs, including diabetic neuropathy.
7) Psychiatric disorders.
8) Multiple levels spinal canal stenosis requiring decompression at three or more levels
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiaki Toyama
Organization Keio University, School of Medicine, Tokyo, Japan
Division name Department of Orthopedic Surgery,
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Morio Matsumoto
Organization Keio University, School of Medicine, Tokyo, Japan
Division name Department of Orthopedic Surgery,
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Homepage URL
Email

Sponsor
Institute Department of Orthopedic Surgery, School of Medicine, Keio University, Tokyo, Japan
Institute
Department

Funding Source
Organization Department of Orthopedic Surgery, School of Medicine, Keio University, Tokyo, Japan
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

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 慶應義塾大学医学部

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 20 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 present prospective randomized control study confirmed that split laminectomy for LCS reduces acute postoperative wound pain, compared with conventional laminectomy, possibly because of minimized damages to the paraspinal muscles.
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
2004 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2004 Year 12 Month 01 Day
Last follow-up date
2007 Year 12 Month 01 Day
Date of closure to data entry
2009 Year 12 Month 01 Day
Date trial data considered complete
2009 Year 12 Month 01 Day
Date analysis concluded
2009 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 11 Month 19 Day
Last modified on
2009 Year 11 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003386

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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