A Prospective, Single Center, Observational Study to Assess the Rapid Recovery After Cardiac Surg… (NCT05578651) | Clinical Trial Compass
WithdrawnNot Applicable
A Prospective, Single Center, Observational Study to Assess the Rapid Recovery After Cardiac Surgery Using SternaLock XP
Stopped: Zimmer Biomet has no current plans to market this product in EMEA.
United States0Started 2024-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Exclusion Criteria
Pre-operative
* Emergent or salvage cardiac acuity, i.e., patients undergoing cardiopulmonary resuscitation en-route to the operating room or prior to induction of anesthesia
* Active or latent infection (with positive culture)
* Documented foreign body sensitivity, allergy, or intolerance to metals.
* Rapid bone absorption condition, metabolic bone disease, cancer, tumor, or tumor like condition of the bone, end-stage malignant disease, or other unexplained disease.
* Mental/ neurologic conditions rendering patients u…