NCT04081233

Brief Summary

The purpose of this study is to compare the usual care alone to usual care plus early surgical stabilization in adult trauma patients who have been admitted with rib fractures, to evaluate for heterogeneity of treatment effect in high risk subgroups and to determine the the impact of multiple rib fractures on post-discharge health status and time to return to work or usual physical activity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 9, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

February 23, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 21, 2024

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

2.9 years

First QC Date

September 4, 2019

Results QC Date

December 26, 2023

Last Update Submit

March 31, 2024

Conditions

Trauma ChestRib Fracture Multiple

Outcome Measures

Primary Outcomes (1)

  • Hospital Length of Stay

    Number of days patient is in the hospital

    180 days after admission

Secondary Outcomes (27)

  • Mortality

    180 days after admission

  • Incidence of Respiratory Failure Requiring Mechanical Ventilation Greater Than 24 Hours

    24 hours after hospital admission

  • Number of Patients Requiring Tracheostomy

    Hospital discharge (about 20 to 30 days)

  • Number of Patients Who Developed Pneumonia During the Hospitalization

    6 months after admission

  • Number of Patients Who Received Regional Analgesia

    6 months after admission

  • +22 more secondary outcomes

Study Arms (2)

Early surgical stabilization

EXPERIMENTAL

This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.

Procedure: surgical stabilization

Usual care

ACTIVE COMPARATOR

This arm will be usual care only. Usual care will include pain managment.

Procedure: Usual care

Interventions

surgical stabilizationPROCEDURE

Surgical procedure utilizing any commercially available internal rib fixation system

Also known as: Rib plating
Early surgical stabilization
Usual carePROCEDURE

Usual care typically consists of breathing exercises and pain control,often including opioids

Usual care

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Blunt trauma mechanism
  • Severe chest wall injury (defined by one of the 3 below):
  • Radiographic flail segment (defined as greater than 2 fractures in greater than 3 consecutive ribs) or greater than 5 consecutive rib fractures or greater than 1 rib fractures with bicortical displacement
  • At least one true rib (1-7) fractured and accessible for stabilization

You may not qualify if:

  • Severe traumatic brain injury (best resuscitated GCS less than 8 as measured at 24 hours)
  • Spinal cord injury
  • Pre-existing congestive heart failure or oxygen-dependent pulmonary disease
  • Any reason for which SSRF could not occur within 72 hours of admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Thoracic Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

Title
David E. Meyer, MD, MS, FACS
Organization
The University of Texas Health Science Center at Houston
David.E.Meyer@uth.tmc.edu
713-500-7244

Study Officials

  • David E Meyer, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 4, 2019

First Posted

September 9, 2019

Study Start

February 23, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

April 2, 2024

Results First Posted

February 21, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)