UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002786
Receipt number 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 18:27:48

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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