Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain (RESTORE)

Inclusion Criteria:

• Patients undergoing median sternotomy;
• Patients eighteen (18) years of age or older;
• Patients presenting two or more risk factors such as diabetes mellitus, Chronic Obstructive Pulmonary Disease, obesity (BMI > 30), osteoporosis, Renal failure, Chronic steroid use, Immunosuppression, Redo sternotomy, Neurologic dysfunction severely affecting ambulation,
• Off mid-line sternotomy
• bilateral IMA use
• Long cardio-pulmonary bypass runs
• Transverse fractures of the sternum

Exclusion Criteria:

• Patients with a non-standard sternotomy;
• Patients with an off-midline sternotomy that reduced the bony margin to <2mm
• Patients under eighteen (18) years of age;
• Patients that are pregnant or currently lactating;
• Patients presenting intra-operative conditions that would require the use of rigid fixation and/or additional post-sternotomy mechanical support beyond wire cerclage due to surgical evaluation,
• Patients defined within the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) functional Class IV for congestive heart failure,
• 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;
• Patients undergoing post-operative revision procedures that treat the original sternotomy in such a way as to affect outcome (antibiotic irrigation, debridement or other treatment to the osteotomy);
• Patients unwilling or unable to return for follow-up;
• Lacking the ability to follow instructions;
• Intraoperative death.