UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Treatment using the antibiotic bone cement for the infectious joint disease
Title of the study (Brief title)	Treatment using the antibiotic bone cement for the infectious joint disease
Region	Japan

Condition
Condition	Infectious joint disease
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the effectiveness for the infectious joint disease of the antibiotic bone cement
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	healing ofinfection
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	Single arm
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	Put antibiotic bone cementin the infectious joint
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	infectious joint disease patient
Key exclusion criteria	dementia
Target sample size	15

Research contact person
Name of lead principal investigator	Takeyuki Tanaka
Organization	The University of Tokyo Hospital
Division name	Orthopaedic Surgery
Address	7-3-1 Hongo, Bunkyo, Tokyo, Japan
TEL	03-3815-5411
Email	tanakata-ort@h.u-tokyo.ac.jp

Public contact
Name of contact person	Takeyuki Tanaka
Organization	The University of Tokyo Hospital
Division name	Orthopaedic Surgery
Address	7-3-1 Hongo, Bunkyo, Tokyo, Japan
TEL	03-3815-5411
Homepage URL
Email	tanakata-ort@h.u-tokyo.ac.jp

Sponsor
Institute	The University of Tokyo Hospital
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	The University of Tokyo Hospital
Organization
Division
Category of Funding Organization	Self funding
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	2015 Year 06 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2003 Year 01 Month 01 Day
Anticipated trial start date	2003 Year 02 Month 20 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	2015 Year 05 Month 28 Day
Last modified on	2016 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020528