Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Zimmer Biomet
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain
