UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026771 |
|---|---|
| Receipt number | R000030735 |
| Scientific Title | Feasibility study of the safety of long-segment posterior cervical fusion surgery with the Ap-FGF coating cervical pedicle screws for cervical vertebrae disease |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2019/04/02 15:16:46 |
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Basic information
Public title
Feasibility study of the safety of long-segment posterior cervical fusion surgery with the Ap-FGF coating cervical pedicle screws for cervical vertebrae disease
Acronym
Ap-FGF CPS study
Scientific Title
Feasibility study of the safety of long-segment posterior cervical fusion surgery with the Ap-FGF coating cervical pedicle screws for cervical vertebrae disease
Scientific Title:Acronym
Ap-FGF CPS study
Region
| Japan |
Condition
Condition
cervical disease
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate about the safety of Ap-FGF coating pedicle scerws
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of all adverse events that occurred during the clinical trials such as infection, death, fracture, a malignant tumor, and neuropathy due to the Ap-FGF pedicle screws.
Key secondary outcomes
Incidence of loosening and breakage of each pedicle screw.
time for bone union.
JOA score,JOACMEQ
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Ap-FGF coating pedicle screws are implanted in the caudal end of the fixation range at the time of the surgery
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients who receives long-segment cervical posterior fusion surgery
Key exclusion criteria
1.The patient who has past history of cervical surgery, pyogenic spondylitis, and vertebral tumor.
2.The patient who receives cervical anterior fusion surgery/
3.The diabetic that it is poor in control
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Yamazaki |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Department of Orthopedic surgery
Zip code
305-8577
Address
1-1-1 Tennodai, Tsukuba, Ibaraki Pref
TEL
029-853-3219
seikei@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Hara |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Department of Orthopedic surgery
Zip code
305-8577
Address
1-1-1 Tennodai, Tsukuba, Ibaraki Pref
TEL
029-853-3219
Homepage URL
seikei@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Japan Society of the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba, Dept. of Orthopaedic Surgery.
Address
1-1-1,Tennodai,Tsukuba,Ibaraki,Japan
Tel
029-853-3219
seikei@md.tsukuba.ac.jp
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
筑波大学附属病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | 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
| 2017 | Year | 03 | Month | 29 | Day |
Last modified on
| 2019 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030735
| 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 |
