Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain

Median sternotomy patients will be randomized to either wire or rigid fixation groups. A
scheduled evaluation period will record clinical parameters. Enrollment has ended with one
hundred forty (140) patients.

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.