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

NCT05578651 | Withdrawn FDA Device

• 1 other identifier: 0821-02
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Rigid Plate Fixation; Median Sternotomy

Outcome Measures

Primary Outcomes (1)

• Incidence of sternal wound infection

  Rate of deep sternal wound infection and superficial sternal wound infection

  30 days

Secondary Outcomes (6)

• Quality of recovery after surgery

  60 days

• Days alive and out of the hospital

  60 days

• Disability-free survival

  60 days

• Pain score

  60 days

• Opioid medication usage

  60 days

Study Arms (1)

SternaLock XP

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

Device: SternaLock XP

Interventions

SternaLock XP 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

SternaLock XP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 13, 2022
• Study Start: March 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: January 16, 2025

Record last verified: 2025-01

Locations

US (1)