RACE XP: A Prospective, Single Center, Observational Study to Assess the Rapid Recovery After Cardiac Surgery Using SternaLock XP
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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:
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Quality of recovery after surgery (QoR-15)
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Days alive out of the hospital and at home (DAH)
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Disability-free survival (WHODAS 2.0.)
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Pain scores: Likert scale 1-10
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Opioid pain medication usage
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Spirometry: inspiratory vital capacity (IVC), as a measure of lung function recovery
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| SternaLock XP Median sternotomy with rigid plate fixation (SternaLock XP) as the sole closure method |
Device: SternaLock 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
|
Outcome Measures
Primary Outcome Measures
- Incidence of sternal wound infection [30 days]
Rate of deep sternal wound infection and superficial sternal wound infection
Secondary Outcome Measures
- Quality of recovery after surgery [60 days]
QoR-15 instrument
- Days alive and out of the hospital [60 days]
Calculation of time
- Disability-free survival [60 days]
WHODAS 2.0 instrument
- Pain score [60 days]
Numerical Rating Pain Score
- Opioid medication usage [60 days]
Milligrams of morphine equivalency administered
- Inspirometry vital capacity [60 days]
Milliliters of spirometry capacity
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male and female
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≥ 18 years of age, no upper limit
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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
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Willing to sign Informed Consent prior to the cardiac surgical procedure
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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
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Willing and able to provide follow-up information up to 60-days post-operative Exclusion Criteria
Pre-operative
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Emergent or salvage cardiac acuity, i.e., patients undergoing cardiopulmonary resuscitation en-route to the operating room or prior to induction of anesthesia
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Active or latent infection (with positive culture)
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Documented foreign body sensitivity, allergy, or intolerance to metals.
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Rapid bone absorption condition, metabolic bone disease, cancer, tumor, or tumor like condition of the bone, end-stage malignant disease, or other unexplained disease.
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Mental/ neurologic conditions rendering patients unwilling or incapable of following post-operative care instructions.
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Functional disability affecting gait, balance or mobility.
Operative
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Delayed sternal closure required for any reason (e.g., sent to ICU with open chest wound)
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Intra-operative conditions that, in the opinion of the operating surgeon, would preclude the use of rigid plate fixation.
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Insufficient quantity of sternal bone or limited blood supply as assessed by the operating surgeon using his or her professional judgment at the time of closure.
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Intraoperative death prior to device placement
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Catholic Medical Center | Manchester | New Hampshire | United States | 03102 |
Sponsors and Collaborators
- Zimmer Biomet
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0821-02