UMIN-CTR Clinical Trial

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

Lumbar spinal canal stenosis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Postoperative wound pain.
Low back pain

Key secondary outcomes

JOA score, VAS, MRI finding, serum CRP and CPK concentration

Study type

Interventional

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

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

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

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

N/A

Name of secondary funder(s)

N/A

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

慶應義塾大学医学部

Date of disclosure of the study information

2009

Year

11

Month

20

Day

URL releasing protocol

Publication of results

Partially published

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

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 related 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