UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030804 |
|---|---|
| Receipt number | R000035175 |
| Scientific Title | The study of new bone substitute (AFFINOS) in bone osteoconductivity: bone microstructure analysis using high resolution CT |
| Date of disclosure of the study information | 2018/01/15 |
| Last modified on | 2024/09/02 10:18:42 |
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Basic information
Public title
The study of new bone substitute (AFFINOS) in bone osteoconductivity: bone microstructure analysis using high resolution CT
Acronym
The study of new bone substitutes (AFFINOS) in bone osteoconductivity
Scientific Title
The study of new bone substitute (AFFINOS) in bone osteoconductivity: bone microstructure analysis using high resolution CT
Scientific Title:Acronym
The study of new bone substitutes (AFFINOS) in bone osteoconductivity
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the bone regeneration of grafted bone substitute by using HR-pQCT
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Bone mineral density, bone microarchitecture, bone strength estimated using micro-finite element 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
Uncontrolled
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Bioresorbable bone-graft substitute (AFFINOS)
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
The patient with knee osteoarthritis, scheduled to have tibial osteotomy
A written informed consent for the participation in the study
Key exclusion criteria
Patients judged to be inadequate for this study by investigators
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Osaki |
Organization
Nagasaki University graduate school of biomedical sciences
Division name
Department of orthopaedic surgery
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
095-819-7321
mosaki@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Ko |
| Middle name | |
| Last name | Chiba |
Organization
Nagasaki University Hospital
Division name
Department of orthopaedic surgery
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
095-819-7321
Homepage URL
kohchiba@estate.ocn.ne.jp
Sponsor or person
Institute
Nagasaki University Hospital
Department of orthopaedic surgery
Institute
Department
Personal name
Funding Source
Organization
Kuraray Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Clinical Research Review Board in Nagasaki University
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
Tel
095-819-7229
gaibushikin@ml.nagasaki-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
| 2018 | Year | 01 | Month | 15 | 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
5
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Data analysis is delayed.
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
| 2018 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 14 | Day |
Last modified on
| 2024 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035175
