UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039964 |
|---|---|
| Receipt number | R000042762 |
| Scientific Title | Clinical experience with silver oxide-containing hydroxyapatite coated spinal interbody implant : prospective multicenter study |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2020/06/01 16:33:04 |
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Basic information
Public title
Clinical experience with silver oxide-containing hydroxyapatite coated spinal interbody implant : prospective multicenter study
Acronym
Ag-HA spinal cage clinical experience: prospective multicenter study
Scientific Title
Clinical experience with silver oxide-containing hydroxyapatite coated spinal interbody implant : prospective multicenter study
Scientific Title:Acronym
Ag-HA spinal cage clinical experience: prospective multicenter study
Region
| Japan |
Condition
Condition
lumbar degenerative disease
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the efficacy and safety ot Ag-HA coated spinal interbody cage
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
bone fusion rate(6month, 1 ,2 year)
Key secondary outcomes
adverse events(infection rate, implant loosening, argria)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
lumbar degenerative disease
Key exclusion criteria
prior lumbar surgery
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | tadatsugu |
| Middle name | |
| Last name | morimoto |
Organization
Saga university
Division name
Department of orhtopedics surgery
Zip code
840-8501
Address
nabeshima 5-1-1, saga city
TEL
0952342343
sakiyuki0830@gmail.com
Public contact
Name of contact person
| 1st name | tadatsugu |
| Middle name | |
| Last name | morimoto |
Organization
Saga university
Division name
Department of orhtopedics surgery
Zip code
840-8501
Address
nabeshima 5-1-1, saga city
TEL
0952342343
Homepage URL
morimot3@cc.saga-u.ac.jp
Sponsor or person
Institute
Department of orhtopedics surgery, Saga university
Institute
Department
Personal name
Funding Source
Organization
Kyocera, medical div
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
saga university hospital clinical research center
Address
Nabeshima5-1-1. Saga city
Tel
09523400
kenkyu-shinsei@ml.cc.saga-u.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | 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
| 2019 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
safety
efficacy
Management information
Registered date
| 2020 | Year | 03 | Month | 27 | Day |
Last modified on
| 2020 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042762
