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Sternum Fixation Device

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

N/A
Waitlist Available
Research Sponsored by Zimmer Biomet
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 days
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Rigid Plate Fixation
  • Median Sternotomy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Wound Infection
Secondary study objectives
Days alive and out of the hospital
Disability-free survival
Inspirometry vital capacity
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: SternaLock XPExperimental Treatment1 Intervention
Median sternotomy with rigid plate fixation (SternaLock XP) as the sole closure method

Find a Location

Who is running the clinical trial?

Zimmer BiometLead Sponsor
378 Previous Clinical Trials
68,050 Total Patients Enrolled
~18 spots leftby Sep 2025
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