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New sternal fixation device study

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
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032180146
Enrollment
70
Registered
2019-02-21
Start date
2017-04-17
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

Cardiovascular Diseases

Interventions

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

Sponsors

Arai Hirokuni
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adult patients who undergo cardiovascular surgery with full sternotomy

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

MeasureTime frame
Displacement of sternal halves (CT scan): 6 months after surgery

Secondary

MeasureTime 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

Contacts

Public ContactKiyotoshi Oishi

Tokyo Medical and Dental University

oishi.cvsg@tmd.ac.jp+81-3-5803-5270

Outcome results

None listed

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