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

Median Sternotomy Clinical Trial

— RACE XP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05578651
• Other study ID #: 0821-02
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: October 31, 2025

Study information

• Verified date: October 2022
• Source: Zimmer Biomet
• Contact: Carl F Lipp, BS
• Phone: 9703312921
• Email: carl.lipp[@]zimmerbiomet.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: October 31, 2025
• Est. primary completion date: September 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Median Sternotomy

Intervention

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

Locations

Country	Name	City	State
United States	Catholic Medical Center	Manchester	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of sternal wound infection	Rate of deep sternal wound infection and superficial sternal wound infection	30 days
Secondary	Quality of recovery after surgery	QoR-15 instrument	60 days
Secondary	Days alive and out of the hospital	Calculation of time	60 days
Secondary	Disability-free survival	WHODAS 2.0 instrument	60 days
Secondary	Pain score	Numerical Rating Pain Score	60 days
Secondary	Opioid medication usage	Milligrams of morphine equivalency administered	60 days
Secondary	Inspirometry vital capacity	Milliliters of spirometry capacity	60 days