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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039964
Receipt No. 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

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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
Email 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
Email morimot3@cc.saga-u.ac.jp

Sponsor
Institute Department of orhtopedics surgery, Saga university
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042762

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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