UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014103 |
|---|---|
| Receipt number | R000016415 |
| Scientific Title | Application of the photofunctionalization to the titanium spacer for spinal interbody fusion. |
| Date of disclosure of the study information | 2014/06/01 |
| Last modified on | 2019/04/27 06:37:24 |
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Basic information
Public title
Application of the photofunctionalization to the titanium spacer for spinal interbody fusion.
Acronym
Photofunctionalization in spinal fusion.
Scientific Title
Application of the photofunctionalization to the titanium spacer for spinal interbody fusion.
Scientific Title:Acronym
Photofunctionalization in spinal fusion.
Region
| Japan |
Condition
Condition
1)Lumbar spodylolisthesis 2)Lumbar lysis 3)Lumbar canal stenosis 4)spinal deformity 5)Lumbar disc herniation
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the improvement of fixation by the photofunctionalization to the orthopaedic titanium implant
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluate the new bone formation around the implants in the lumbar interbody fusion with an image analysis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Non-photofuntinalized orthopaedic implant
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patient who needs the lumbar interbody fusion in a lumbar degenerative disease.
Key exclusion criteria
The patients with malignant tumor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Ishidou |
Organization
Graduate school of medical and dental Science, Kagoshima university
Division name
Departments of Medical Joint Materials
Zip code
Address
Sakuragaoka8-35-1, Kagoshima, Japan
TEL
099-275-5381
ishidou@m2.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Ishidou |
Organization
Graduate school of medical and dental Science, Kagoshima university
Division name
Departments of Medical Joint Materials
Zip code
Address
Sakuragaoka8-35-1, Kagoshima, Japan
TEL
099-275-5381
Homepage URL
ishidou@m2.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima university
Institute
Department
Personal name
Funding Source
Organization
Ushio Inc.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2014 | Year | 06 | Month | 01 | 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
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 28 | Day |
Last modified on
| 2019 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016415
