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

NCT ID: NCT05578651

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-31
• Study Completion Date: 2025-10-31

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

Conditions

Rigid Plate Fixation; Median Sternotomy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

SternaLock XP

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

SternaLock XP

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

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

• 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Catholic Medical Center

Manchester, New Hampshire, United States

Countries

United States

Other Identifiers

0821-02

Identifier Type: -

Identifier Source: org_study_id