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NCT01783483 · ClinicalTrials.gov registry record · NA
An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery
A NA study, sponsored by Zimmer Biomet.
- Completed
- Registry status
- NA
- Development phase
- 236
- Enrollment target
NCT01783483: Completed NA study, sponsored by Zimmer Biomet.
NCT01783483 is a NA study that has completed, run by Zimmer Biomet. The registered enrollment target is 236 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01783483, a NA study, has completed, sponsored by Zimmer Biomet.
- COMPLETED
- Registry status
- NA
- Development phase
- 236 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate sternal bone healing following a full median sternotomy versus standard of care for sternal closure with wire cerclage. Additional outcomes on post-operative pain and analgesic usage, patient function and quality of life, and complications will also be collected. A health economics study will also be conducted, in which cost and billing data will be collected from sites participating in this clinical study.
Primary Outcome
Parameters for scoring: 0 - Nonunion: No contact between sternal halves, absence of gap mineralization, and sclerotic osteotomy margins similar to that of cortical bone. Worst outcome 1. \- Indeterminate: No contact or mineralization between the sternal halves, but osteotomy margins were nonsclerotic, concave, or irregular 2. \- Early healing: Faint mineralization between noncontacting sternal halves, or a thin (1 mm) bridge of bone connecting the sternal halves anteriorly or posteriorly, or n
Interventions
- DEVICE SternaLock Blue closure system
- DEVICE Suture Wire
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 236 participants |
| Start Date | 2013-01 |
| Est. Completion | 2016-12 |
| Phase | NA |
What the finished NCT01783483 record still lists
NCT01783483 is an interventional study that assigns participants to a tested intervention. The registered 236 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which SternaLock Blue closure system is the first listed.
NCT01783483 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01783483 about?
NCT01783483 is a clinical study titled "An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery". The primary objective of this study is to evaluate sternal bone healing following a full median sternotomy versus standard of care for sternal closure with wire cerclage. Additional outcomes on post-operative pain and analgesic usage, patient function and quality of life, and complications will also...
What is the current status of trial NCT01783483?
This trial is currently completed. It is a NA study. The enrollment target is 236 participants. The study started on 2013-01. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01783483?
The interventions under investigation include: SternaLock Blue closure system (DEVICE), Suture Wire (DEVICE).
Who is sponsoring clinical trial NCT01783483?
This trial is sponsored by Zimmer Biomet, which has 115 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01783483's enrollment target sits among peer trials
236 461st of 2000 higher than 1,540 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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