Status:
TERMINATED
Orthosis of Acute Traumatic Rib Fractures Via RibFx Belt for Pain Alleviation and Improved Pulmonary Function
Lead Sponsor:
University of Vermont Medical Center
Collaborating Sponsors:
PelvicBinder, Inc.
Conditions:
Rib Fracture
Rib Fracture Multiple
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 the...
Detailed Description
The purpose of this study is to ascertain whether the use of next generation rib orthosis belts (such as the RibFx) can improve patient outcomes following traumatic rib fractures within our population...
Eligibility Criteria
Inclusion
- Adult person age 18-80 admitted with at least one acute traumatic closed rib fracture to the University of Vermont Medical Center
Exclusion
- Pediatric (\<18 year old) and Geriatric (\>80 year old) patients
- Patients who are intubated on arrival or within first 24 hours of admission or with Glasgow Coma Scale (GCS) \< 14 (altered or depressed consciousness)
- Pregnant patients
- Patients who undergo operative rib fixation for their rib fractures (such as open reduction internal fixation, or rib plating)
- Patients with chest wall deformity, lacerations, burns, or soft tissue injuries that preclude placement of the RibFx belt
- Patients with an additional mechanism of injury that would create severe distracting pain, as determine by the admitting team.
- Isolated 1st rib or 2nd rib fractures
Key Trial Info
Start Date :
July 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2020
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03846024
Start Date
July 25 2018
End Date
April 9 2020
Last Update
January 12 2023
Active Locations (1)
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1
University of Vermont Medical Center
Burlington, Vermont, United States, 05401