UMIN-CTR Clinical Trial

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
Email	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
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	Medical Ethics Committee Secretariat of Shimane University Faculty of Medicine
Address	89-1, Enya-cho, Izumo-shi, Shimane, Japan
Tel	0853202515
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040131