- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06464302
Investigation of the Effect of Age and Injury Severity on Short-term Intra-hospital Outcomes After Surgical Stabilized Rib Fractures
April 28, 2026 updated by: University Hospital Muenster
The study aims to investigate the effect of surgical stabilisation of rib fractures (SSRF) on clinical outcomes measured during the hospital stay (mortality, days on a mechanical ventilator, intensive care unit and hospital length of stay, rate of complications).
Furthermore, the effect of the patients age and overall injury severity on the outcomes after SSRF will be investigated.
We hypothesise that the combination of high age and high injury severity will lead to worse outcomes after SSRF.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
1064
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
-
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North Rhine-Westphalia
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Münster, North Rhine-Westphalia, Germany, 48149
- Department for trauma, hand and reconstructive surgery, University hospital Muenster
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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
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
The Patients will be sampled from all patients treated in the department for trauma, hand and reconstructive surgery of the university hospital Muenster
Description
Inclusion Criteria:
- Patients of the University Hospital Muenster
- Coded serial rib fractures (ICD S22.4 and S22.5)
- Treatment for the rib fractures between 2019 and 2023
Exclusion Criteria:
- pathological rib fractures (due to suspected malignancy)
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 |
Intervention / Treatment |
|---|---|
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Operative
Patients receiving surgical stabilisation of rib fractures (SSRF) by any operative technique
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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).
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)
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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
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.
|
Mortality rate from injury to initial hospital discharge, binary
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From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
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Intensive care unit length of stay
Time Frame: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
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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.
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From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intubation rate
Time Frame: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
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Proportion of patients intubated at any time
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From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
|
|
Multi-organ failure
Time Frame: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
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Rate of Multi-organ failure
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From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
|
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Single organ failure
Time Frame: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
|
Rate of single organ failure
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From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
|
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Sepsis
Time Frame: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
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Rate of Sepsis
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From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
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|
Lung-failure
Time Frame: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
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Rate of Lung-failure
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From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
|
|
Clinical outcome
Time Frame: At the time point of initial hospital discharge or at death, whichever came first, assessed up to 2 month.
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Clinical outcome according to the Glasgow outcome scale (GOS)
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At the time point of initial hospital discharge or at death, whichever came first, assessed up to 2 month.
|
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Duration of hospital stay
Time Frame: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
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Duration of hospital stay in days from injury to initial discharge
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From injury up to 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
Investigators
- 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)
May 1, 2024
Primary Completion (Actual)
December 31, 2025
Study Completion (Actual)
December 31, 2025
Study Registration Dates
First Submitted
May 31, 2024
First Submitted That Met QC Criteria
June 12, 2024
First Posted (Actual)
June 18, 2024
Study Record Updates
Last Update Posted (Actual)
April 29, 2026
Last Update Submitted That Met QC Criteria
April 28, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UKM_UCH_2024_002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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