NCT05578651

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-09-01
• Completion: 2025-10-01
• First posted: 2022-10-13
• Last updated: 2025-01-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study