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Sternalock Versus Wires for Sternal Closure Study

NCT03282578 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-04-17

No results posted yet for this study

Summary

Design:

Investigator Initiated Prospective Randomised Trial

Study Centre's:

Melbourne Private Hospital Royal Melbourne Hospital

Study Hypothesis:

Use of the SternaLock 360 will reduce the incidence of sternal motion \> 2mm by absolute difference of 40% at 6 weeks of surgery compared to stainless steel wiring.

Use of the SternaLock 360 will improve bone healing and quality of recovery after surgery compared to stainless steel wiring

Study Objective:

To determine if the SternaLock 360 system reduces sternal instability, increases bone healing, and improves quality of recovery compared to stainless steel wiring of the sternum, after cardiac surgery involving median sternotomy

Inclusion Criteria:

Age ≥ 18 year old Elective cardiac surgery Primary cardiac surgical procedure No evidence of infection at time of surgery Sufficient English language to complete the Postoperative Quality of Recovery Survey

Exclusion Criteria:

Previous sternotomy (redo) Clinical sternal deformity Home locality preventing follow-up (e.g. remote regional, interstate or overseas patient)

Number of Planned Subjects:

50

Conditions

  • Cardiac Surgery
  • Sternal Closure

Interventions

DEVICE

Sternalock 360 sternal plating system

The SternaLock 360 system is a band and plating system designed to improve sternal stability. 3 bands surround the sternum to oppose the bones (like wires), but an additional 3 plate system prevents anterior posterior displacement and provides a rigid fixation.

DEVICE

Sternal Wires

Stainless steel wires are applied in a "figure of 8" configuration to close the sternum

Sponsors & Collaborators

Principal Investigators

  • Alistair Royse, MD · Melbourne Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-05
Primary Completion
2018-11-25
Completion
2018-11-25

Countries

  • Australia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03282578 on ClinicalTrials.gov