UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of bioabsorbable artifical bone for craniofacial surgery
Title of the study (Brief title)	Efficiency of bioabsorbable artifical bone
Region	Japan

Condition
Condition	Craniofacial anomaly
Classification by specialty	Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The efficicacy of artificial bone which is replaced to autologous bone is evaluated.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The bone volume of replacement to autologous bone
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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The bioresorbable artificial bone was put in the bone defect.
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	Not applicable
Age-upper limit	16 years-old >
Gender	Male and Female
Key inclusion criteria	The patients who had bone defects in the craniofacial region, and performed the operation for the defect.
Key exclusion criteria	The patients who could not come to the hospital over 1 years.
Target sample size	20

Research contact person
Name of lead principal investigator	Kazuo Kishi
Organization	Keio University School of Medicine
Division name	Department of Plastic and Reconstructive Surgery
Address	35, Shinanomachi, Shinjuku-ku, Tokyo
TEL	+81353633814
Email	kkishi@a7.keio.jp

Public contact
Name of contact person	Yoshiaki Sakamoto
Organization	Keio University School of Medicine
Division name	Department of Plastic and Reconstructive Surgery
Address	35, Shinanomachi, Shinjuku-ku, Tokyo
TEL	+81353633814
Homepage URL
Email	ysakamoto@z8.keio.jp

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 02 Month 22 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 07 Month 24 Day
Anticipated trial start date	2015 Year 07 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 02 Month 22 Day
Last modified on	2018 Year 02 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030161