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NCT03846024 · ClinicalTrials.gov registry record · NA
Orthosis of Acute Traumatic Rib Fractures Via RibFx Belt for Pain Alleviation and Improved Pulmonary Function
A NA study, sponsored by University of Vermont Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 27
- Enrollment target
NCT03846024: Clinical Trial NA study, sponsored by University of Vermont Medical Center.
NCT03846024 is a NA study that was terminated before completion, run by University of Vermont Medical Center. The registered enrollment target is 27 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03846024, a NA study, was terminated before completion, sponsored by University of Vermont Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 27 participants
- Enrollment target
Study Summary
Acute traumatic rib fractures are a common issue for patients of trauma surgeons. They inflict substantial morbidity, the most dreaded and consequential of which are pulmonary complications. While these fractures are often treated non-operatively, there is a continued need for effective adjuvant treatments to improve rib fracture pain and outcomes. Prior studies have evaluated outcome measures for traumatic rib fractures that include respiratory failure, tracheostomy requirement, ICU length of stay, hospital length of stay, narcotic requirement, daily maximum incentive spirometry volume, pneumonia, and mortality . Rib belts, which have been present since at least 1945, have long been used to provide pain relief via chest wall stabilization \[3\]. However there is an extreme paucity of literature regarding their clinical efficacy, and their use has largely been abandoned due to concerns that they may have been overly constricting and resulted in poorer respiratory (pulmonary/breathing) outcomes. Newer generation rib belts are more elastic and theoretically less constricting than their earlier generation predecessors, however their clinical efficacy has not been yet demonstrated. The investigators will therefore plan to perform a prospective trial to determine if these rib strapping devices are effective clinical tools in the traumatic rib fracture population. The goal of the study is institutional quality improvement, to determine if the investigators see benefit of these devices for the pain management of our trauma population. The investigators will also conduct this as a pilot trial for hopeful future research applications, however the overall goal is institutional improvement. Patients determined to be eligible for the study by the admitting physician (and per the previously defined criteria) will be recruited to enroll in the project within the first 24 hours of their hospital admission. Recruited patients will be offered the opportunity to consent to enrollme
Primary Outcome
Compare pain control in patients with non-operatively managed traumatic rib fractures via subjective/qualitative self-reporting of pain control via questionnaires Pain control will be predominantly measured utilizing a likert scale score of 1 to 10, with a score of 1 denoting the lowest amount of pain and a score of 10 indicating the highest amount of pain. This will assist us in comparing patient pain scores in an objective manner.
Interventions
- DEVICE RibFx Orthosis Belt
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2018-07-25 |
| Est. Completion | 2020-04-09 |
| Phase | NA |
Why NCT03846024 stopped before completion
NCT03846024 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which RibFx Orthosis Belt is the first listed.
NCT03846024 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03846024 about?
NCT03846024 is a clinical study titled "Orthosis of Acute Traumatic Rib Fractures Via RibFx Belt for Pain Alleviation and Improved Pulmonary Function". Acute traumatic rib fractures are a common issue for patients of trauma surgeons. They inflict substantial morbidity, the most dreaded and consequential of which are pulmonary complications. While these fractures are often treated non-operatively, there is a continued need for effective adjuvant tre...
What is the current status of trial NCT03846024?
This trial is currently terminated. It is a NA study. The enrollment target is 27 participants. The study started on 2018-07-25. Estimated completion is 2020-04-09.
What interventions are being tested in trial NCT03846024?
The interventions under investigation include: RibFx Orthosis Belt (DEVICE).
Who is sponsoring clinical trial NCT03846024?
This trial is sponsored by University of Vermont Medical Center, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03846024's enrollment target sits among peer trials
27 1708th of 2000 higher than 291 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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