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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Median Sternotomy; Rigid Plate Fixation
• Intervention / Treatment: Device: SternaLock XP

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 Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Carl F Lipp, BS; Phone Number: 9703312921; Email: carl.lipp@zimmerbiomet.com

Study Locations

• United States
  • New Hampshire
    • Manchester, New Hampshire, United States, 03102
      • Catholic Medical Center
      • Principal Investigator: David Caparrelli, MD
      • Contact: David Caparrelli, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Received median sternotomy with rigid plate fixation after a cardiac procedure (e.g., valve replacement or repair, bypass grafting)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SternaLock XP; Median sternotomy with rigid plate fixation (SternaLock XP) as the sole closure method	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of sternal wound infection	Rate of deep sternal wound infection and superficial sternal wound infection	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of recovery after surgery	QoR-15 instrument	60 days
Days alive and out of the hospital	Calculation of time	60 days
Disability-free survival	WHODAS 2.0 instrument	60 days
Pain score	Numerical Rating Pain Score	60 days
Opioid medication usage	Milligrams of morphine equivalency administered	60 days
Inspirometry vital capacity	Milliliters of spirometry capacity	60 days

Collaborators and Investigators

• Sponsor: Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): September 28, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: October 11, 2022
• First Submitted That Met QC Criteria: October 11, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 0821-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No