UMIN-CTR Clinical Trial

Basic information
Public title	Randomized controlled trial evaluating the effect of new sternal fixation device for the patients who undergo open heart surgery
Acronym	New sternal fixation device study
Scientific Title	Randomized controlled trial evaluating the effect of new sternal fixation device for the patients who undergo open heart surgery
Scientific Title:Acronym	New sternal fixation device study
Region	Japan

Condition
Condition	Patients who undergo cardiovascular surgery with full sternotomy
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the postoperative displacement of sternal halves with new sternal fixation device to that with simple wire cerclage
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Displacement of sternal halves (CT scan): 6 months after surgery
Key secondary outcomes	Displacement of sternal halves (CT scan): 2weeks and 3 months after surgery Dihisecnce, Bone union, and CBDA; Cortical bone density area (CT scan): 2weeks, 3months, and 6months after surgery Sternal infection and Pain score: 1week, 2weeks, 3weeks, 6weeks, 3months, and 6months after surgery Quality of Life: 2weeks, 3weeks, 6weeks, 3months, and 6months after surgery

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Sternal closure with new sternal fixation device, which is inserted in bone marrow, followed by wire cerclage
Interventions/Control_2	Sternal closure with simple wire cerclage
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	Not applicable
Gender	Male and Female
Key inclusion criteria	20 years of age and more
Key exclusion criteria	Emergency, Diabetes (HbA1c is 8.0% and more), Hemodialysis, Steroid, Immunosuppressant, Severe COPD, Ventricular assist device, Infectious endocarditis, and Pacemaker lead infection
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Hirokuni Middle name Last name Arai
Organization	Tokyo Medical and Dental University
Division name	Department of Cardiovascular Surgery
Zip code	113-8519
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, JAPAN
TEL	03-5803-5267
Email	hiro.cvsg@tmd.ac.jp

Public contact
Name of contact person	1st name Kiyotoshi Middle name Last name Oishi
Organization	Tokyo Medical and Dental University
Division name	Department of Cardiovascular Surgery
Zip code	113-8519
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, JAPAN
TEL	03-5803-5270
Homepage URL
Email	oishi.cvsg@tmd.ac.jp

Sponsor
Institute	Tokyo Medical And Dental University, University Hospital of Medicine
Institute
Department

Funding Source
Organization	Teijin Medical Technology Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tokyo Medical and Dental University Hospital of Medicine, Clinical Reserch Center
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, JAPAN
Tel	03-5803-5612
Email	tiken.crc@tmd.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	東京医科歯科大学医学部附属病院（東京都） 武蔵野赤十字病院（東京都） 青梅市立総合病院（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 24 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	70
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	under review
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	Completed
Date of protocol fixation	2016 Year 12 Month 19 Day
Date of IRB	2016 Year 12 Month 15 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date	2021 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 01 Month 20 Day
Last modified on	2022 Year 07 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028502