UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002113 |
|---|---|
| Receipt number | R000002575 |
| Scientific Title | A Prospective Multicenter Study of Combined Lumbar Spinal Canal Stenosis and Peripheral Arterial Disease in an Orthopedic Surgery |
| Date of disclosure of the study information | 2009/06/24 |
| Last modified on | 2009/06/23 21:40:19 |
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Basic information
Public title
A Prospective Multicenter Study of Combined Lumbar Spinal Canal Stenosis and Peripheral Arterial Disease in an Orthopedic Surgery
Acronym
Combined Lumbar Spinal Canal Stenosis and Peripheral Arterial Disease
Scientific Title
A Prospective Multicenter Study of Combined Lumbar Spinal Canal Stenosis and Peripheral Arterial Disease in an Orthopedic Surgery
Scientific Title:Acronym
Combined Lumbar Spinal Canal Stenosis and Peripheral Arterial Disease
Region
| Japan |
Condition
Condition
Lumbar Spinal Canal Stenosis and Peripheral Arterial Disease
Classification by specialty
| Cardiology | Vascular surgery | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Diagnosis of Lumbar Spinal Canal Stenosis and Peripheral Arterial Disease
Basic objectives2
Others
Basic objectives -Others
Diagnosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Rate of Combination of Lumbar Spinal Canal Stenosis and Peripheral Arterial Disease
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Lumbar MRI, Ankle-brachial Index, Toe-brachial Index
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Lumbar spine canal stenosis patients with an IC walking distance of less than 500 m who visited an outpatient department affiliated with the Nogoya Spine Group (NSG) in the three months from June to August 2008.
Key exclusion criteria
artificial dialysis, patients who have received operation of their blood vessels.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukihiro Matsuyama |
Organization
Nagoya University Graduate School of Medicine
Division name
Orthopaedics
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nagoya University Graduate School of Medicine
Division name
Orthopaedics
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Orthopaedic Surgery, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2009 | Year | 06 | Month | 24 | 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
| 2008 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 06 | Month | 23 | Day |
Last modified on
| 2009 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002575
