Sternal Closure With SternaLock 360: First in Man Study

Study Overview
=================
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.

Official Title
-----------------
SternaLock 360 First in Man Study: A Prospective, Randomized Controlled Trial

Conditions
-----------------
Sternal Fracture

Intervention / Treatment
-----------------
* Device: SternaLock 360
* Device: Wire Cerclage


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparison of intervention using sternal closure with 360 plating system, to closure of the sternum using wire cerclage
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SternaLock 360<br>Sternal closure performed with SternaLock 360 as a primary closure system | Device: SternaLock 360<br>* Sternal closure with SternaLock 360<br>|
| Active Comparator: Wire Cerclage<br>Sternal closure performed with standard wire cerclage as a primary closure system | Device: Wire Cerclage<br>* Sternal closure with standard wire cerclage<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sternal Bone Healing | Sternal bone healing score as defined by CT scan assessment at 6 months postoperatively | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sternal Pain | 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. | Baseline, postoperative day 3 to day 7, 1-month post-op, 3-month post-op and 6-month post-op | 
| Analgesic usage | Tabulation of all pain medication administered in pre-specified time points | Baseline, postoperative day 0 to day 7, 1-month post-op, 3-month post-op and 6-month post-op | 
| Upper Extremities Functional Status | 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. | Baseline, 1-month post-op, 3-month post-op and 6-month post-op | 
| Return to Work | Assessment of working status of patients before and after cardiac surgery using 7-categorical question questionnaire. | Baseline, 1-month post-op, 3-month post-op and 6-month post-op | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rigid Fixation, Sternal Plating, Sternal Closure, Sternalock