Surgical Stabilisation of Rib Fractures in Non-ventilated Patients

NCT06464289 | Completed

• 2 other identifiers: UKM_UCH_2024_0012023-007
• Study Type: observational
• Target: 35,974
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

surgical stabilisation of rib fractures; non-ventilator-dependent

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Proportion of patients intubated at any time

  From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.

• Duration of hospital stay

  From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.

• Rate of single organ failure

  From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.

• Rate of multiorgan failure

  From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.

• Rate of respiratory failure

  From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.

Study Arms (2)

Operative

Patients receiving surgical stabilisation of rib fractures (SSRF) by any operative technique

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)

Other: Non-operative management of rib fractures

Interventions

Surgical stabilisation of rib fractures (SSRF) PROCEDURE

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).

Operative

Non-operative management of rib fractures OTHER

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; Operative

Eligibility Criteria

• Age: 10 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients within the dataset of the TraumaRegister DGU

You may qualify if:

• Rib AIS of ≥ 3
• Initial hospital treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Muenster: lead
• TraumaRegister® DGU: collaborator

Study Sites (1)

Department for trauma, hand and reconstructive surgery, University hospital Muenster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Related Publications (1)

• 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.

  PMID: 39856261 DERIVED

MeSH Terms

Conditions

Rib Fractures; Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries; Thoracic Injuries

Study Officials

• Steffen Rosslenbroich, PD Dr. med.

  Department for trauma, hand and reconstructive surgery, University hospital Muenster

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 18, 2024
• Study Start: April 13, 2024
• Primary Completion: July 31, 2024
• Study Completion: September 30, 2024
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)