Rib FracturesNCT06464289
Surgical Stabilisation of Rib Fractures in Non-ventilated Patients
An observational study of Rib Fractures and Thorax; Fracture, run by University Hospital Muenster at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 100 years
- Conditions the study is for
- Rib Fractures, Thorax; Fracture
- 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
- 35,974 participants
- Where
- 1 siteGermany
- Study dates
- 13 Apr 2024to 30 Sep 2024
- 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 10 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients within the dataset of the TraumaRegister DGU
Who may be able to join
- Rib AIS of ≥ 3
- Initial hospital treatment
Who cannot join
- 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
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
Official title: 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.
- Conditions
- Rib Fractures, Thorax; Fracture
- Being tested
- Surgical stabilisation of rib fractures (SSRF), Non-operative management of rib fractures
- Keywords
- surgical stabilisation of rib fractures, non-ventilator-dependent
- 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
Number of patients who died in the hospital and mortality rate up to hospital discharge
Measured: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Duration of mechanical ventilation
The duration in hours a patient spent intubated 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.
Duration of intensive care unit 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)
Proportion of patients intubated at any time
Proportion of patients intubated at any time from time of injury to initial hospital discharge
Measured: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Duration of hospital stay
Duration of the initial hospital stay in days
Measured: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Rate of single organ failure
The Rate of single organ failure from injury to initial hospital discharge
Measured: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Rate of multiorgan failure
The Rate of multiorgan failure from injury to initial hospital discharge
Measured: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Rate of respiratory failure
The Rate of respiratory failure from injury to initial hospital discharge
Measured: From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Rate of sepsis
The Rate of sepsis from injury to initial hospital discharge
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
Measured: At the time of 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 start13 Apr 2024
- Primary completion31 Jul 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 35,974 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- TraumaRegister® DGU
- 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
- NCT06464289
- Sponsor's protocol ID
- UKM_UCH_2024_001
- Other IDs
- 2023-007
- Status last verified
- Dec 2024
- First submitted
- 31 May 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huelskamp MD, Duesing H, Lefering R, Raschke MJ, Rosslenbroich S; TraumaRegister DGU. Surgical stabilisation of rib fractures in non-ventilated patients: a retrospective propensity-matched analysis using the data from the trauma registry of the German Trauma Society (TraumaRegister DGUⓇ). Eur J Trauma Emerg Surg. 2025 Jan 24;51(1):55. doi: 10.1007/s00068-024-02756-9.
PubMed 39856261
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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))
- ClinicalTrials.gov ID
- NCT06464289
- Acronym / sponsor ID
- UKM_UCH_2024_001
- Conditions
- Rib Fractures, Thorax; Fracture
- Keywords
- surgical stabilisation of rib fractures, non-ventilator-dependent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35,974 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- TraumaRegister® DGU
- Study start
- 13 Apr 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 30 Sep 2024 (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 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 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
- 10 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients within the dataset of the TraumaRegister DGU
Key inclusion criteria (2 listed)
- Rib AIS of ≥ 3
- Initial hospital treatment
Key exclusion criteria (3 listed)
- 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
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.
Number of patients who died in the hospital and mortality rate up to hospital discharge
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
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.
7 secondary outcomes
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.
Duration of hospital stay
Time frame: 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.
Rate of multiorgan failure
Time frame: 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.
Rate of sepsis
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 of 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 17 Dec 2024.
- Derived from this study: PubMed 39856261Huelskamp MD, Duesing H, Lefering R, Raschke MJ, Rosslenbroich S; TraumaRegister DGU. Surgical stabilisation of rib fractures in non-ventilated patients: a retrospective propensity-matched analysis using the data from the trauma registry of the German Trauma Society (TraumaRegister DGUⓇ). Eur J Trauma Emerg Surg. 2025 Jan 24;51(1):55. doi: 10.1007/s00068-024-02756-9.
- Individual participant dataSharing planned: No
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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 Thorax; Fracture, 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 2 inclusion and 3 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 17 Dec 2024. 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 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06464289, which also lists 1 linked publication.
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 17 Dec 2024.