Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT05578651
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
Study:
NCT05578651
Study Brief:
Protocol Section:
NCT05578651