Rib FracturesNCT06464302
Investigation of the Effect of Age and Injury Severity on Short-term Intra-hospital Outcomes After Surgical Stabilized Rib Fractures
An observational study of Rib Fractures and Rib Trauma, run by University Hospital Muenster at 1 site in Germany.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 0 to 100 years
- Conditions the study is for
- Rib Fractures, Rib Trauma, Rib Fracture Multiple
- What is being tested?
- Surgical stabilisation of rib fractures (SSRF) and Non-operative management of rib fractures
- Type of treatment
- Surgery or procedure
- How many people
- 1,064 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- pathological rib fractures (due to suspected malignancy)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department for trauma, hand and reconstructive surgery, University hospital Muenster
Münster, North Rhine-Westphalia, 48149
About this study
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.
- Conditions
- Rib Fractures, Rib Trauma, Rib Fracture Multiple, Thorax; Fracture
- Being tested
- Surgical stabilisation of rib fractures (SSRF), Non-operative management of rib fractures
- Keywords
- Surgical stabilisation of rib fractures (SSRF)
- Medical subject headings
- Rib Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical stabilisation of rib fractures (SSRF)Procedure or surgery
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).
Non-operative management of rib fracturesOther
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
| Study group | Role | What they receive |
|---|---|---|
| Operative | Patients receiving surgical stabilisation of rib fractures (SSRF) by any operative technique Receives: Procedure: Surgical stabilisation of rib fractures (SSRF); Other: Non-operative management of rib fractures | |
| Non-operative | Patients not receiving surgical stabilisation of rib fractures (SSRF) Receives: Other: Non-operative management of rib fractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
In hospital-mortality
Mortality rate from injury to initial hospital discharge, binary
Measured: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Intensive care unit length of stay
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.
Measured: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Secondary outcomes (7)
Intubation rate
Proportion of patients intubated at any time
Measured: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Multi-organ failure
Rate of Multi-organ failure
Measured: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Single organ failure
Rate of single organ failure
Measured: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Sepsis
Rate of Sepsis
Measured: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Lung-failure
Rate of Lung-failure
Measured: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Clinical outcome
Clinical outcome according to the Glasgow outcome scale (GOS)
Measured: At the time point of initial hospital discharge or at death, whichever came first, assessed up to 2 month.
Duration of hospital stay
Duration of hospital stay in days from injury to initial discharge
Measured: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start1 May 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rib FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,064 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steffen Rosslenbroich, PD Dr. med., Study director, Department for trauma, hand and reconstructive surgery, University hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464302
- Sponsor's protocol ID
- UKM_UCH_2024_002
- Status last verified
- Apr 2026
- First submitted
- 31 May 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Age and Injury Severity on Short-term Intra-hospital Outcomes After Surgical Stabilized Rib Fractures
- ClinicalTrials.gov ID
- NCT06464302
- Acronym / sponsor ID
- UKM_UCH_2024_002
- Conditions
- Rib Fractures, Rib Trauma, Rib Fracture Multiple, Thorax; Fracture
- Keywords
- Surgical stabilisation of rib fractures (SSRF)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,064 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operative | – | Procedure: Surgical stabilisation of rib fractures (SSRF), Other: Non-operative management of rib fracturesPatients receiving surgical stabilisation of rib fractures (SSRF) by any operative technique |
| Non-operative | – | Other: Non-operative management of rib fracturesPatients not receiving surgical stabilisation of rib fractures (SSRF) |
Who may qualify
- Ages
- 0 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- pathological rib fractures (due to suspected malignancy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Procedure or surgery | Operative |
| Non-operative management of rib fracturesAny 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 | Other | Non-operative, Operative |
Primary outcome
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
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.
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.
7 secondary outcomes
Intubation rate
Time frame: 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.
Single organ failure
Time frame: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Sepsis
Time frame: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Lung-failure
Time frame: 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.
Duration of hospital stay
Time frame: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steffen Rosslenbroich, PD Dr. med. study director
Department for trauma, hand and reconstructive surgery, University hospital Muenster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rib Fractures and Rib Trauma, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In hospital-mortality (time frame: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.