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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035228
Receipt No. 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 2018/12/12

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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 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
Middle name
Last name Tsutomu Yoshikane
Organization Shimane University Faculty of Medicine
Division name Neurosurgery
Zip code
Address 89-1, Enya-cho, Izumo-shi, Shimane, Japan
TEL 0853-20-2245
Email ytsutomu@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsutomu Yoshikane
Organization Shimane University Faculty of Medicine
Division name Neurosurgery
Zip code
Address 89-1, Enya-cho, Izumo-shi, Shimane, Japan
TEL 0853-20-2245
Homepage URL
Email ytsutomu@med.shimane-u.ac.jp

Sponsor
Institute Shimane University Faculty of Medicine Department of Neurosurgery
Institute
Department

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
Address
Tel
Email

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
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
2018 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040131

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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