Sternal Closure With SternaLock 360: First in Man Study

Not Applicable

Completed

• Conditions: Sternal Fracture
• Interventions: Device: SternaLock 360; Device: Wire Cerclage

• Registration Number: NCT02686099
• Lead Sponsor: Zimmer Biomet

Brief Summary

The SternaLock 360 Sternal Closure Device combines the techniques of rigid fixation with a cerclage material into a single sternal closure system. The cerclage material serves to facilitate sternal approximation, and the plates and screws serve to provide rigid fixation and prevent sternal movement and separation. The combination of a cerclage material in combination with plate and screw fixation may also lead to increased stability compared to either method used as a standalone means of closure.

Detailed Description

The purpose of this study is to evaluate a new technology for sternal closure that combines rigid plate fixation with a cerclage material in patients undergoing a cardiac surgery subsequent to a full median sternotomy. This study will evaluate intraoperative outcomes related to the surgical technique and performance of the device, sternal healing and stability, sternal wound complications and postoperative recovery (e.g. pain and functional status) in patients closed with this device. For comparative purposes, a control group of wire cerclage patients will be included.

Study Timeline

• Study Start: 2015-07-04
• Study First Submitted: 2016-02-09
• Study First Submitted QC: 2016-02-16
• Study First Posted: 2016-02-19
• Primary Completion: 2017-09-05
• Status Verified: 2018-01
• Study Completion: 2018-01-15
• Last Update Submitted: 2018-01-16
• Last Update Posted: 2018-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients undergoing a standard midline sternotomy as a result of a cardiac surgical procedure (i.e. coronary artery bypass graft (CABG) and/or valve replacement along with other cardiac surgical procedures)
• Patients ≥ 30 years of age
• Patients who sign the Informed Consent

Exclusion Criteria

Pre-Operative

• Patients with endstage renal failure who are on dialysis or post transplant patients
• Patients taking chronic (>30 days) pre-operative narcotics
• Patients taking chronic (>30 days) steroids, immunosuppressant (including biologic immunosuppressants such as Enbrel), or chemotherapeutics (e.g. methotrexate). Patients using a steroid inhaler for asthma should not be excluded.
• Patients with confirmed HIV with a viral load of >10,000 copies
• Patients with an active infection that is currently being treated
• Patients with history or confirmed metal allergy or foreign body sensitivity
• Patients with a previous partial or full midline sternotomy
• Patients with previous radiation treatment of the chest
• Patients defined within the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) functional Class IV for congestive heart failure: i.e., patients with cardiac disease resulting in inability to carry on any physical activity without discomfort (CCS ; NYHA)
• Patients presenting emergent/salvage cardiac acuity as defined per the Society of Thoracic Surgeons (STS) guidelines: i.e., patients undergoing cardiopulmonary resuscitation en route to the operating room or prior to induction of anesthesia (STS)
• Patients unwilling or unable to return for follow-up

Exclusion Criteria: Operative

• Patients requiring delayed sternotomy closure
• Patients with transverse sternal fractures located beneath the cerclage band on the SternaLock 360 Device.
• Patients presenting intra-operative conditions that in the opinion of the treating surgeon would require or preclude a specific method for sternal closure, or who are not able to be closed per the protocol.
• Use of non resorbable (beeswax) bonewax along the sternotomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SternaLock 360	SternaLock 360	Sternal closure performed with SternaLock 360 as a primary closure system
Wire Cerclage	Wire Cerclage	Sternal closure performed with standard wire cerclage as a primary closure system

Primary Outcome Measures

Name	Time	Method
Sternal Bone Healing	6 months	Sternal bone healing score as defined by CT scan assessment at 6 months postoperatively

Secondary Outcome Measures

Name	Time	Method
Sternal Pain	Baseline, postoperative day 3 to day 7, 1-month post-op, 3-month post-op and 6-month post-op	Pain scores obtained at pre-specified time points in 4 modalities: at rest, after using incentive spirometer, after ambulation and after forced coughing. Likert scale questionnaire.
Analgesic usage	Baseline, postoperative day 0 to day 7, 1-month post-op, 3-month post-op and 6-month post-op	Tabulation of all pain medication administered in pre-specified time points
Upper Extremities Functional Status	Baseline, 1-month post-op, 3-month post-op and 6-month post-op	Functional status of upper extremities are evaluated using 20 items that are rated on a 5-point Likert scale known as Upper Extremity Functional Index questionnaire.
Return to Work	Baseline, 1-month post-op, 3-month post-op and 6-month post-op	Assessment of working status of patients before and after cardiac surgery using 7-categorical question questionnaire.

Trial Locations

Locations (1)

Groote Schuur Hospital; 🇿🇦 Cape Town, South Africa