Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-30 @ 10:43 PM
Study NCT ID:
NCT05578651
Status:
WITHDRAWN
Last Update Posted:
2025-01-16
First Post:
2022-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective, Single Center, Observational Study to Assess the Rapid Recovery After Cardiac Surgery Using SternaLock XP
Sponsor:
Zimmer Biomet
Organization:
Study Overview
Official Title:
A Prospective, Single Center, Observational Study to Assess the Rapid Recovery After Cardiac Surgery Using SternaLock XP
Status:
WITHDRAWN
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Zimmer Biomet has no current plans to market this product in EMEA.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RACE XP
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.
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: