UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Use of an Injectable Complex of Beta-Phosphate Granules, Hyaluronate, and Fibroblast Growth Factor-2 on Repair of Fracture with Bone Defects.
Title of the study (Brief title)	Use of an Injectable Complex of Beta-TCP, Hyaluronate, and FGF-2 on Repair of Fracture with Bone Defects.
Region	Japan

Condition
Condition	Fracture with Bone Defects
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We evaluated effects of an injectable complex of beta-tricalcium phosphate (beta-TCP) granules, hyaluronate, and recombinant human fibroblast growth factor-2 (rhFGF-2) on repair of Fracture with Bone Defects.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	X-ray and CT Evaluation of Bone Union
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	expanded access
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	A complex of beta-TCP granules, hyaluronate, and rhFGF-2 in a cylinder is injected through the tip of the great trochanter to the base of the lesser trochanter during surgery under fluoroscopy in operation.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	And adaptation of the fracture cases with bone defect in the 20 years of age or older.
Key exclusion criteria	The following will be the key exclusion criteria. Children Malignant tumor present example There is a history of allergy to beta-TCP, hyaluronic acid, and FGF-2 After more than four weeks after the injury open fracture
Target sample size	20

Research contact person
Name of lead principal investigator	Shigeru Soshi
Organization	Department of Orthopedic Surgery, Jikei University School of Medicine
Division name	Department of Orthopedic Surgery
Address	3-19-18, Nishishimbashi, Minato-ku, Tokyo
TEL	03-3433-1111
Email	kijijma@jikei.ac.jp

Public contact
Name of contact person	Eiji Kijima
Organization	Department of Orthopedic Surgery, Jikei University School of Medicine
Division name	Department of Orthopedic Surgery
Address	3-19-18, Nishishimbashi, Minato-ku, Tokyo
TEL	03-3433-1111
Homepage URL
Email	kijijma@jikei.ac.jp

Sponsor
Institute	Department of Orthopedic Surgery, Jikei University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Department of Orthopedic Surgery, Jikei University School of Medicine
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	2016 Year 07 Month 19 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 03 Month 04 Day
Anticipated trial start date	2016 Year 03 Month 04 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	2016 Year 07 Month 17 Day
Last modified on	2016 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025862