Median Sternotomy Clinical Trial
Official title:
A Prospective, Single Center, Observational Study to Assess the Rapid Recovery After Cardiac Surgery Using SternaLock XP
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 ;
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