Surgical Stabilisation of Rib Fractures in Non-ventilated Patients

December 11, 2024 updated by: University Hospital Muenster

Surgical Stabilisation of Rib Fractures in Non-ventilated Patients: a Retrospective Propensity-matched Analysis Using the Data From the German National Trauma Registry (TraumaRegister of the German Trauma Society (DGU))

The aim of the study is to investigate the effect of surgical stabilisation of rib fractures on clinical outcomes in patients that are not dependent on mechanical ventilation at the time of the treatment decision. To this end, data on all eligible patients will be extracted from the TraumaRegister® DGU. Baseline demographics will be analysed using descriptive statistics. Propensity matching will be conducted between the operative cohort (receiving SSRF by any technique) and the conservative cohort (not receiving SSRF). The effect of SSRF on the outcome variables will then be assessed using appropriate statistical tests.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35974

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Münster, NRW, Germany, 48149
        • Department for trauma, hand and reconstructive surgery, University hospital Muenster

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All patients within the dataset of the TraumaRegister DGU

Description

Inclusion Criteria:

  • Rib AIS of ≥ 3
  • Initial hospital treatment

Exclusion Criteria:

  • Intubated preclinically or in the emergency department
  • Glasgow coma scale (GCS) < 9 at the time of the primary survey in the emergency department
  • No in-patient hospital management

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Operative
Patients receiving surgical stabilisation of rib fractures (SSRF) by any operative technique
Procedure: Surgical stabilisation of rib fractures (SSRF)
Surgical stabilisation of rib fractures using any fixation technique (including but not limited to plate fixation, intramedullary fixation, wire fixation) via any operative approach (including but not limited to open external approach, minimally invasive approach, thoracoscopic approach, thoracotomy approach).
Other: Non-operative management of rib fractures
Any supportive or specific treatment of rib fractures excluding surgical stabilisation of rib fractures. This includes, but is not limited to analgesia, physiotherapy, non-invasive ventilation, mechanical ventilation, oxygen-supplementation.
Non-operative
Patients not receiving surgical stabilisation of rib fractures (SSRF)
Other: Non-operative management of rib fractures
Any supportive or specific treatment of rib fractures excluding surgical stabilisation of rib fractures. This includes, but is not limited to analgesia, physiotherapy, non-invasive ventilation, mechanical ventilation, oxygen-supplementation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
In-hospital mortality
Time Frame: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Number of patients who died in the hospital and mortality rate up to hospital discharge
From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Duration of mechanical ventilation
Time Frame: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
The duration in hours a patient spent intubated from the time of hospital admission to the time of initial hospital discharge
From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Duration of intensive care unit stay.
Time Frame: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
The duration in days a patient spent in the intensive care unit from the time of hospital admission to the time of initial hospital discharge.
From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of patients intubated at any time
Time Frame: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Proportion of patients intubated at any time from time of injury to initial hospital discharge
From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Duration of hospital stay
Time Frame: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Duration of the initial hospital stay in days
From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Rate of single organ failure
Time Frame: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
The Rate of single organ failure from injury to initial hospital discharge
From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Rate of multiorgan failure
Time Frame: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
The Rate of multiorgan failure from injury to initial hospital discharge
From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Rate of respiratory failure
Time Frame: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
The Rate of respiratory failure from injury to initial hospital discharge
From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Rate of sepsis
Time Frame: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
The Rate of sepsis from injury to initial hospital discharge
From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Clinical outcome
Time Frame: At the time of initial hospital discharge or death, whichever came first, assessed up to 2 month.
Clinical outcome according to the Glasgow Outcome Scale
At the time of initial hospital discharge or death, whichever came first, assessed up to 2 month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Muenster

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
TraumaRegister® DGU

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Steffen Rosslenbroich, PD Dr. med., Department for trauma, hand and reconstructive surgery, University hospital Muenster

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 13, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UKM_UCH_2024_001
  • 2023-007 (TraumaRegister DGU)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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