Orthosis of Acute Traumatic Rib Fractures Via RibFx Belt for Pain Alleviation and Improved Pulmonary Function

NCT03846024 | Terminated Results DMC FDA Device

• 1 other identifier: IRB CHRMS 18-0646
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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 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 enrollment in the study and will be assigned by the study team into either the intervention (RibFx belt +current standard of care) or control (current standard of care) arm in a quasi-experimental prospective design: untreated control group with dependent pretest and posttest samples. In this manner, the intervention arm will be both compared to themselves (pretest vs. posttests) as well as to a control group not exposed to the intervention. The relevant study materials will be included in their paper (physical) and electronic chart. Patients upon enrollment in the study will undergo an initial assessment that will include their baseline pain scores, narcotic consumption, incentive spirometry scores, and the subjective self-reported results of their questionnaire (the pre-test questionnaire- see attached). Patients will continue to be scored on objective (incentive spirometry results, opioid pain medicine consumption) and subjective variables (pain scores) during their hospital course. Between 24-48 hours after enrollment, they will be prompted to again complete a similar 2nd questionnaire post-test (if they are discharged from the hospital at this point in the time course, they will be sent home with the questionnaire and prompted to complete it at home). At their follow up appointment in trauma clinic (which will be coordinated by the research team to be as close as possible to 3 weeks post injury), they will have the opportunity to again voluntarily complete a final short questionnaires (post-test) that assess their pain control and respiratory function over the last 3 weeks. At this point, their involvement in the trial will be complete. Patients themselves will play an active role in data collection during the trial, and will be instructed and prompted in how to do so. Patients will be expected to fill out a worksheet on a daily basis, both while inpatient and after discharge, on their daily incentive spirometry scores as well as their minimum and maximum pain scale scores. This will be used to supplement the survey or questionnaire data, as well as the objective data from the electronic medical record. The investigators will ultimately compare groups using a quasi-experimental design as follows: Untreated control group with dependent pretest and posttest samples. This will allow for a direct comparison of patient to patient within the intervention arm (patient pretest result serving as control compared to posttest result) . To observe for temporal variability, their will be a control group with no intervention as well (no rib belt worn) , however the principle aim of the study is the comparison of patients to themselves in a pre-test, post-test fashion.

Conditions

Rib Fracture; Rib Fracture Multiple; Trauma; Trauma Chest; Trauma Injury; Trauma, Multiple

Keywords

RibFx; PelvicBinder; Rib Fractures; Trauma; Pulmonary toilet; Incentive Spirometry

Outcome Measures

Primary Outcomes (4)

• Rib Fracture Subjective Self-Reported Pain (Inpatient)

  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.

  Inpatient Stay

• Narcotic/ Opioid Pain Medication Requirement After Rib Fracture (Inpatient)

  Count of participants who required any use of a prescribed pain medication at any point throughout their inpatient stay.

  Inpatient Stay

• Narcotic/ Opioid Pain Medication Requirement After Rib Fracture (Home)

  Count of participants who required any use of a prescribed pain medication at any point between their discharge from the hospital and their follow up appointment at 4 weeks.

  4 Week Follow Up

• Rib Fracture Subjective Self-Reported Pain (Home)

  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.

  4 Week Follow Up

Secondary Outcomes (4)

• Incentive Spirometry Score (Inpatient)

  Inpatient Stay

• Pneumonia Post Rib Fracture

  4 Week Follow Up

• Atelectasis Post Rib Fracture

  4 Week Follow Up

• Incentive Spirometry Score (Home)

  4 Week Follow Up

Study Arms (2)

RibFx belt arm

EXPERIMENTAL

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.

Device: RibFx Orthosis Belt

Control

NO 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).

Interventions

RibFx Orthosis Belt DEVICE

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.

RibFx belt arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult person age 18-80 admitted with at least one acute traumatic closed rib fracture to the University of Vermont Medical Center

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont Medical Center: lead
• PelvicBinder, Inc.: collaborator

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Related Links

• RibFx Belt Product Site

MeSH Terms

Conditions

Rib Fractures; Wounds and Injuries; Thoracic Injuries; Accidental Injuries; Multiple Trauma

Condition Hierarchy (Ancestors)

Fractures, Bone

Limitations and Caveats

This clinical trial was terminated on 5/25/2022 due to inadequate enrollment and data collection due to the COVID-19 pandemic. Of the 27 participants who were enrolled in the trial, only 5 patients yielded full data collection in all questionnaires/assessments. Other challenges including loss to follow up, discharge from the hospital before certain time points, and limited completion of the home log, all significantly limit our ability to analyze the data as intended.

Results Point of Contact

• Title: Ethan Jones
• Organization: University of Vermont

ethan.d.jones@med.uvm.edu

802-656-9437

Study Officials

• Ajai Malhotra, MD

  University of Vermont Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Acute Care Surgery Division

Study Record Dates

• First Submitted: December 15, 2018
• First Posted: February 19, 2019
• Study Start: July 25, 2018
• Primary Completion: April 9, 2020
• Study Completion: April 9, 2020
• Last Updated: January 12, 2023
• Results First Posted: January 12, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)