Clinical trial NCT05578651: A Prospective, Single Center, Observational Study to Assess the Rapid Recovery After Cardiac Surgery Using SternaLock XP
Official title: A Prospective, Single Center, Observational Study to Assess the Rapid Recovery After Cardiac Surgery Using SternaLock XP
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Rigid Plate Fixation
Median Sternotomy
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2022-10-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Received median sternotomy with rigid plate fixation after a cardiac procedure (e.g., valve replacement or repair, bypass grafting)

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

Eligibility 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:

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

Primary outcomes:
measure: Incidence of sternal wound infection
timeFrame: 30 days
Secondary outcomes:
measure: Quality of recovery after surgery
timeFrame: 60 days
measure: Days alive and out of the hospital
timeFrame: 60 days
measure: Disability-free survival
timeFrame: 60 days
measure: Pain score
timeFrame: 60 days
measure: Opioid medication usage
timeFrame: 60 days
measure: Inspirometry vital capacity
timeFrame: 60 days
Other outcomes:
Locations:
city: Manchester
country: United States
facility: Catholic Medical Center
state: New Hampshire
Study officials:
References: