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

NCT06464302 | Completed

• 1 other identifier: UKM_UCH_2024_002
• Study Type: observational
• Target: 1,064
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rib Fractures; Rib Trauma; Rib Fracture Multiple; Thorax; Fracture

Keywords

Surgical stabilisation of rib fractures (SSRF)

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (7)

• Intubation rate

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

• Multi-organ failure

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

• Single organ failure

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

• Sepsis

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

• Lung-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: 0 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

The Patients will be sampled from all patients treated in the department for trauma, hand and reconstructive surgery of the university hospital Muenster

You may qualify if:

• 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

You may not qualify if:

• pathological rib fractures (due to suspected malignancy)

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

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

Münster, North Rhine-Westphalia, 48149, Germany

Location

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: May 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

DE (1)