Loading clinical trials...

A Prospective, Single Center, Observational Study to Assess the Rapid Recovery After Cardiac Surgery Using SternaLock XP | Clinical Trials | Clareo Health

WITHDRAWN

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

NCT05578651•Zimmer Biomet

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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.
+2 more criteria

Locations (1)

Catholic Medical Center

Manchester, New Hampshire, United States

Key Dates

Start Date

March 1, 2024

Primary Completion Date

September 1, 2025

Completion Date

October 1, 2025

Last Updated

January 16, 2025

Conditions

Rigid Plate FixationMedian Sternotomy

Interventions

SternaLock XP

DEVICE

Ultrasound Guided Bilateral Pectoral Nerve Block Versus Bilateral Transverse Thoracic Plane Block In Pediatric Patients Undergoing Corrective Cardiac Surgeries Requiring Cardiopulmonary Bypass Via Median Sternotomy

NCT06984276

UltrasoundPectoral Nerve Block+5 more

View study

UNKNOWNNA

Transversus Thoracis Muscle Plane Block Plus Rectus Sheath Block in the Perioperative Pain Management of Cardiac Surgery

NCT04838132

Coronary Artery Bypass Grafting or Heart Valve Surgery Via Median Sternotomy

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Ultrasound Guided Bilateral Pectoral Nerve Block Versus Bilateral Transverse Thoracic Plane Block In Pediatric Patients Undergoing Corrective Cardiac Surgeries Requiring Cardiopulmonary Bypass Via Median Sternotomy

Transversus Thoracis Muscle Plane Block Plus Rectus Sheath Block in the Perioperative Pain Management of Cardiac Surgery

Study to Evaluate the Safety and Efficacy of Dermal Injections of JVS-100 Given to Adults Receiving Median Sternotomy