UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010420 |
|---|---|
| Receipt number | R000012190 |
| Scientific Title | A prospective randomized controlled trial comparing traditional trajectory pedicle screw versus cortical bone trajectory screw for degenerative spondylosis. |
| Date of disclosure of the study information | 2013/04/08 |
| Last modified on | 2014/05/12 21:14:56 |
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Basic information
Public title
A prospective randomized controlled trial comparing traditional trajectory pedicle screw versus cortical bone trajectory screw for degenerative spondylosis.
Acronym
A prospective randomized controlled trial comparing traditional trajectory pedicle screw versus cortical bone trajectory screw.
Scientific Title
A prospective randomized controlled trial comparing traditional trajectory pedicle screw versus cortical bone trajectory screw for degenerative spondylosis.
Scientific Title:Acronym
A prospective randomized controlled trial comparing traditional trajectory pedicle screw versus cortical bone trajectory screw.
Region
| Japan |
Condition
Condition
degenerative spondylosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze surgical outcomes of degenerative spondylosis using traditional pedicle screw compared to cortical bone trajectory screw.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
JOA score
JOA-BPEQ
VAS
Key secondary outcomes
rate of union
rate of reduction
change of bone mineral density
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
traditional trajectory pedicle screw
Interventions/Control_2
cortical bone trajectory screw
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients scheduled for posterior fusion surgery for degenerative spondylosis
2)Consent to the trial
3)20 years of age or over
Key exclusion criteria
1)do not use Stryker Spine RADIUS spinal system
2)posterior fixation more than 3 levels
3)spinal tumor
4)pyogenic spondylitis
5)dialysis patients
6)spinal trauma
7)malignant tumors,
dementia,bedridden patients
8)no consent to the trial
9)determination as contraindication by doctors
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Uei |
Organization
Nihon University Itabashi Hospital
Division name
Department of Orthopaedic Surgery
Zip code
Address
30-1 Oyaguchi Kami-cho, Itabashi-ku, Tokyo
TEL
03-3972-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Uei |
Organization
Nihon University Itabashi Hospital
Division name
Department of Orthopaedic Surgery
Zip code
Address
30-1 Oyaguchi Kami-cho, Itabashi-ku, Tokyo
TEL
03-3972-8111
Homepage URL
uei.hiroshi@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Itabashi Hospital
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
日本大学医学部附属板橋病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Terminated
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 04 | Day |
Last modified on
| 2014 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012190
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
