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

Withdrawn

• Conditions: Rigid Plate Fixation; Median Sternotomy
• Interventions: Device: SternaLock XP

• Registration Number: NCT05578651
• Lead Sponsor: Zimmer Biomet

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

Study Timeline

• Study First Submitted: 2022-10-11
• Study First Submitted QC: 2022-10-11
• Study First Posted: 2022-10-13
• Study Start: 2024-03
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-16
• Primary Completion: 2025-09
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SternaLock XP	SternaLock XP	Median sternotomy with rigid plate fixation (SternaLock XP) as the sole closure method

Primary Outcome Measures

Name	Time	Method
Incidence of sternal wound infection	30 days	Rate of deep sternal wound infection and superficial sternal wound infection

Secondary Outcome Measures

Name	Time	Method
Days alive and out of the hospital	60 days	Calculation of time
Quality of recovery after surgery	60 days	QoR-15 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
Disability-free survival	60 days	WHODAS 2.0 instrument

Trial Locations

Locations (1)

Catholic Medical Center; 🇺🇸 Manchester, New Hampshire, United States