A Prospective, Single Center, Observational Study to Assess the Rapid Recovery After Cardiac Surgery Using SternaLock XP (RACE XP)

Zimmer Biomet

Status

Withdrawn

Conditions

Median Sternotomy

Rigid Plate Fixation

Treatments

Device: SternaLock XP

Study type

Observational

Funder types

Industry

Identifiers

NCT05578651

0821-02

Details and patient eligibility

About

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.

Full 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

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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 unwilling or incapable of following post-operative care instructions.
Functional disability affecting gait, balance or mobility.

Operative

Delayed sternal closure required for any reason (e.g., sent to ICU with open chest wound)
Intra-operative conditions that, in the opinion of the operating surgeon, would preclude the use of rigid plate fixation.
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.
Intraoperative death prior to device placement