Investigation of the Effect of Age and Injury Severity on Short-term Intra-hospital Outcomes After Surgical Stabilized Rib Fractures

Rib Fractures Clinical Trial

Official title:

Investigation of the Effect of Age and Injury Severity on Short-term Intra-hospital Outcomes After Surgical Stabilized Rib Fractures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06464302
• Other study ID #: UKM_UCH_2024_002
• Status: Recruiting
• Start date: May 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: University Hospital Muenster
• Contact: Michael D Huelskamp, Dr. med.
• Phone: 0049 (0)251 83 51786
• Email: Michael.Huelskamp[@]ukmuenster.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Fractures, Bone
• Rib Fracture Multiple
• Rib Fractures
• Rib Trauma

Intervention

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

Locations

Country	Name	City	State
Germany	Department for trauma, hand and reconstructive surgery, University hospital Muenster	Münster	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In hospital-mortality	Mortality rate from injury to initial hospital discharge, binary	From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Primary	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.	From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Secondary	Intubation rate	Proportion of patients intubated at any time	From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Secondary	Multi-organ failure	Rate of Multi-organ failure	From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Secondary	Single organ failure	Rate of single organ failure	From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Secondary	Sepsis	Rate of Sepsis	From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Secondary	Lung-failure	Rate of Lung-failure	From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.
Secondary	Clinical outcome	Clinical outcome according to the Glasgow outcome scale (GOS)	At the time point of initial hospital discharge or at death, whichever came first, assessed up to 2 month.
Secondary	Duration of hospital stay	Duration of hospital stay in days from injury to initial discharge	From injury up to initial hospital discharge or death, whichever came first, assessed up to 2 month.