UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035228 |
|---|---|
| Receipt number | R000040131 |
| Scientific Title | Restoration of bone defects at craniotomy using bone graft substitutes made of hydroxyapatite and collagen composite. |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2020/12/13 09:30:08 |
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Basic information
Public title
Restoration of bone defects at craniotomy using bone graft substitutes made of hydroxyapatite and collagen composite.
Acronym
Restoration of bone defects at craniotomy using bone graft substitutes made of hydroxyapatite and collagen composite.
Scientific Title
Restoration of bone defects at craniotomy using bone graft substitutes made of hydroxyapatite and collagen composite.
Scientific Title:Acronym
Restoration of bone defects at craniotomy using bone graft substitutes made of hydroxyapatite and collagen composite.
Region
| Japan |
Condition
Condition
Bone defect caused by craniotomy
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Bone defect occurring during craniotomy is osteolytic occurs over time, a problem in aesthetic surface and intensity surface. The aim is to clarify the hypothesis that using bone graft substitutes made of hydroxyapatite and collagen composite for the bone defect part, it is replaced with new bone and the strength and aesthetic aspects are improved.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Treatment success rate of artificial bone and autogenous bone dust replacement part
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
At the time of surgery, artificial bone is placed 1-6cc.
Interventions/Control_2
At the time of surgery, bone dust occurred at craniotomy is placed.
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
1)Bilateral frontal craniotomy or fronto temporal craniotomy is scheduled.
2)There is no history of surgery such as craniotomy in the scheduled opening range.
3)The age at agreement is 20 years old or over and 90 years old or younger.
4)Consent in writing from the person is obtained for the study participants.
Key exclusion criteria
1) It is known that it is allergic to allergy patients who need treatment, or other porcine collagen-containing preparations.
2) There is a history of inflammation in the skull.
3) received immunosuppressive therapy Within three months ago.
4) pregnant, lactating, or it might be pregnant.
5) undergoing dialysis.
6) has a active and/or progressive malignant tumor.
7) Diabetes mellitus with poor control.
8) has a calcium metabolic diseases requiring treatment.
9) has a bone targeted hormone metabolism abnormalities requiring treatment.
10) has an immune deficiency disease.
Target sample size
31
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Yoshikane |
Organization
Shimane University Faculty of Medicine
Division name
Neurosurgery
Zip code
6938501
Address
89-1, Enya-cho, Izumo-shi, Shimane, Japan
TEL
0853-20-2245
ytsutomu@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsutomu |
| Middle name | |
| Last name | Yoshikane |
Organization
Shimane University Faculty of Medicine
Division name
Neurosurgery
Zip code
6938501
Address
89-1, Enya-cho, Izumo-shi, Shimane, Japan
TEL
0853-20-2245
Homepage URL
ytsutomu@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of Medicine Department of Neurosurgery
Institute
Department
Personal name
Funding Source
Organization
Shimane University
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
Medical Ethics Committee Secretariat of Shimane University Faculty of Medicine
Address
89-1, Enya-cho, Izumo-shi, Shimane, Japan
Tel
0853202515
kenkyu@med.shimane-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
| 2019 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 11 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 12 | Day |
Last modified on
| 2020 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040131
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| Registered date | File name |
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