Median Sternotomy, Rigid Plate Fixation
Conditions
Brief summary
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.
Detailed description
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
Interventions
DEVICESternaLock XP
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
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male and female * ≥ 18 years of age, no upper limit * Undergoing a full standard midline sternotomy as part of an elective or urgent cardiac surgical procedure \[i.e., coronary artery bypass graft (CABG) and/ or valve replacement\] and closed with the SternaLock XP Rigid Fixation System * Willing to sign Informed Consent prior to the cardiac surgical procedure * Willing and able to provide follow-up information up to 60-days post-operative
Exclusion criteria
Inclusion Criteria * Male and female * ≥ 18 years of age, no upper limit * Undergoing a full standard midline sternotomy as part of an elective or urgent cardiac surgical procedure \[i.e., coronary artery bypass graft (CABG) and/ or valve replacement\] and closed with the SternaLock XP Rigid Fixation System * Willing to sign Informed Consent prior to the cardiac surgical procedure * Willing and able to provide follow-up information up to 60-days post-operative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of sternal wound infection | 30 days | Rate of deep sternal wound infection and superficial sternal wound infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days alive and out of the hospital | 60 days | Calculation of time |
| Disability-free survival | 60 days | WHODAS 2.0 instrument |
| Quality of recovery after surgery | 60 days | QoR-15 instrument |
| Opioid medication usage | 60 days | Milligrams of morphine equivalency administered |
| Inspirometry vital capacity | 60 days | Milliliters of spirometry capacity |
| Pain score | 60 days | Numerical Rating Pain Score |
Countries
United States
Outcome results
None listed