Surgical Stabilisation of Rib Fractures in Non-ventilated Patients

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: Completed
• Conditions: Rib Fractures; Thorax; Fracture
• Intervention / Treatment: Procedure: Surgical stabilisation of rib fractures (SSRF); Other: Non-operative management of rib fractures

• Study Type: Observational
• Enrollment (Actual): 35974

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
In-hospital mortality	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	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.	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

Outcome Measure	Measure Description	Time Frame
Proportion of patients intubated at any time	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	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	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	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	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	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	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

• Sponsor: University Hospital Muenster
• Collaborators: TraumaRegister® DGU
• Investigators: Study Director: Steffen Rosslenbroich, PD Dr. med., Department for trauma, hand and reconstructive surgery, University hospital Muenster

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2024
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): September 30, 2024

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): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: surgical stabilisation of rib fractures; non-ventilator-dependent
• Additional Relevant MeSH Terms: Wounds and Injuries; Thoracic Injuries; Fractures, Bone; Rib Fractures
• Other Study ID 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