Sternal Closure With SternaLock 360: First in Man Study

Zimmer Biomet50 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Sternal Fracture

Interventions

SternaLock 360DEVICE

Sternal closure with SternaLock 360

Wire CerclageDEVICE

Sternal closure with standard wire cerclage

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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

Locations (1)

Groote Schuur Hospital

Cape Town, South Africa

Outcomes

Primary Outcomes

Sternal Bone Healing

Sternal bone healing score as defined by CT scan assessment at 6 months postoperatively

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: Baseline, 1-month post-op, 3-month post-op and 6-month post-op

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.