Randomized controlled trial evaluating the effect of new sternal fixation device for the patients who undergo open heart surgery

Randomized controlled trial evaluating the effect of new sternal fixation device for the patients who undergo open heart surgery - New sternal fixation device study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025763

Enrollment

Registered

2017-02-24

Start date

2017-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients who undergo cardiovascular surgery with full sternotomy

Interventions

Sternal closure with new sternal fixation device, which is inserted in bone marrow, followed by wire cerclage Sternal closure with simple wire cerclage

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 20 years of age and more

Exclusion criteria

Exclusion criteria: Emergency, Diabetes (HbA1c is 8.0% and more), Hemodialysis, Steroid, Immunosuppressant, Severe COPD, Ventricular assist device, Infectious endocarditis, and Pacemaker lead infection

Design outcomes

Primary

Measure	Time frame
Displacement of sternal halves (CT scan): 6 months after surgery	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactKiyotoshi Oishi

Tokyo Medical and Dental University Department of Cardiovascular Surgery

oishi.cvsg@tmd.ac.jp03-5803-5270

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026