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RibFx belt arm for Multiple Rib Fractures (RibFx Trial)

N/A
Waitlist Available
Led By Ajai Malhotra, MD
Research Sponsored by University of Vermont Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult person age 18-80 admitted with at least one acute traumatic closed rib fracture to the University of Vermont Medical Center
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 week follow up
Awards & highlights

RibFx Trial Summary

This trial will help determine if newer, less constricting rib belts are effective in treating patients with rib fractures, compared to no belt at all.

Eligible Conditions
  • Multiple Rib Fractures
  • Trauma
  • Traumatic Chest Injury
  • Traumatic Injury
  • Multiple Trauma
  • Rib Fractures

RibFx Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

RibFx Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~inpatient stay
This trial's timeline: 3 weeks for screening, Varies for treatment, and inpatient stay for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Narcotic/ Opioid Pain Medication Requirement After Rib Fracture (Home)
Narcotic/ Opioid Pain Medication Requirement After Rib Fracture (Inpatient)
Rib Fracture Subjective Self-Reported Pain (Home)
+1 more
Secondary outcome measures
Atelectasis Post Rib Fracture
Incentive Spirometry Score (Home)
Incentive Spirometry Score (Inpatient)
+1 more

RibFx Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: RibFx belt armExperimental Treatment1 Intervention
Each patient in the interventional arm will be fitted with a RibFx orthosis belt, which is to be worn during the majority of their day (excluding showering/bathing). It will be encouraged (though not mandatory) to wear at night. Patients in both the control and interventional arm will be expected to participate in pulmonary hygiene / toilet exercises with guided and independent incentive spirometry as per our normal routine and standard of care. There are no other interventions or procedures that the patients will be subjected to for the research trial- other procedures/interventions will be performed only if the clinical care team feels they are indicated.
Group II: ControlActive Control1 Intervention
Patients in the control arm receive normal standard of care for rib fractures at the participating institution. The current standard of care for rib fractures at the University of Vermont (participating institution) is as follows: includes oral and IV analgesia and other multimodal pain control as appropriate, including muscle relaxants such as methocarbamol (robaxin) unless there is a contraindication, pulmonary hygiene/toilet and respiratory care (including frequent evaluations by physicians, respiratory therapists, and nursing staff, early mobilization, and monitoring for pulmonary complication (via vital signs, pulse oximetry, oxygen requirement, chest imaging if appropriate).

Find a Location

Who is running the clinical trial?

PelvicBinder, Inc.UNKNOWN
University of Vermont Medical CenterLead Sponsor
41 Previous Clinical Trials
25,798 Total Patients Enrolled
Ajai Malhotra, MDPrincipal Investigator - University of Vermont Medical Center
University of Vermont Medical Center
M.L.N. Medical College (Medical School)
University Of Tn College Of Medicine (Residency)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants is the trial currently accommodating?

"Affirmative. Information published on clinicaltrials.gov verifies that this study is currently recruiting individuals, with the initial posting made on November 28th 2018 and last updated March 31st 2022. The trial requires 50 participants to be enrolled from a singular site."

Answered by AI

Is the age cutoff for enrollment in this experiment under 35 years?

"This trial seeks participants between the ages of 18 and 80, with 193 studies aimed at younger individuals and 900 for seniors."

Answered by AI

Are there still vacancies available for participation in this clinical trial?

"As evidenced on clinicaltrials.gov, the recruitment process for this medical trial is ongoing with the initial posting of 11/28/2018 and most recent amendment occurring 3/31/2022."

Answered by AI

Who is eligible to take part in this research?

"To be eligible for this experiment, patients must have sustained rib fractures and fall within the age range of 18-80. Altogether, 50 individuals are being enrolled in the trial."

Answered by AI

What are the major goals of this research endeavor?

"This 4 week clinical trial seeks to reduce the amount of narcotic/opioid medication needed for rib fracture patients. Additionally, it will assess hospital and intensive care unit stays as well as patient-reported respiratory health via a COPD Assessment Test (CAT). The CAT comprises 8 questions that are rated from 0 (best) up to 5 (worst), with an overall score calculated at the end."

Answered by AI
~4 spots leftby Mar 2025