The primary objective of this study is to evaluate the post-operative rapid recovery in patients treated with SternaLock XP for rigid sternal fixation with sternal precautions less restrictive than standard of care.
The primary efficacy endpoint of evaluation is defined by the post-operative time back to prior work or life through patient diary. The primary safety endpoint of evaluation is defined by the incidence rate of sternal complications (DSWI \& SSWI) at 30 days post-op. The secondary endpoints of evaluation up to 60-days post-operative are defined by: * Quality of recovery after surgery (QoR-15) * Days alive out of the hospital and at home (DAH) * Disability-free survival (WHODAS 2.0.) * Pain scores: Likert scale 1-10 * Opioid pain medication usage * Spirometry: inspiratory vital capacity (IVC), as a measure of lung function recovery
Study Type
OBSERVATIONAL
Plating system with cable cerclage bands that is used in the stabilization and fixation of fractures of the anterior chest wall, including sternal fixation following sternotomy
Catholic Medical Center
Manchester, New Hampshire, United States
Incidence of sternal wound infection
Rate of deep sternal wound infection and superficial sternal wound infection
Time frame: 30 days
Quality of recovery after surgery
QoR-15 instrument
Time frame: 60 days
Days alive and out of the hospital
Calculation of time
Time frame: 60 days
Disability-free survival
WHODAS 2.0 instrument
Time frame: 60 days
Pain score
Numerical Rating Pain Score
Time frame: 60 days
Opioid medication usage
Milligrams of morphine equivalency administered
Time frame: 60 days
Inspirometry vital capacity
Milliliters of spirometry capacity
Time frame: 60 days
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