New sternal fixation device study (NSX Study)

Completed

• Conditions: Cardiovascular Diseases

• Registration Number: jRCTs032180146

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-17
• Study First Submitted: 2019-02-21
• Last Update Posted: 2021-12-23

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Adult patients who undergo cardiovascular surgery with full sternotomy

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
-		Displacement of sternal halves (CT scan): 6 months after surgery

Secondary Outcome Measures

Name	Time	Method
Displacement of sternal halves	2weeks and 3 months after surgery	CT scan
Dihisecnce, Bone union, and CBDA	2weeks, 3months, and 6months after surgery	Cortical bone density area (CT scan)