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Completed

NCT Number: NCT06464302

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

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.

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Key information

Age range

0 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Münster, North Rhine-Westphalia, 48149, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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).

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

Primary outcomes

  1. In hospital-mortality

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

    Mortality rate from injury to initial hospital discharge, binary

  2. Intensive care unit length of 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.

Secondary outcomes

  1. Intubation rate

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

    Proportion of patients intubated at any time

  2. Multi-organ failure

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

    Rate of Multi-organ failure

  3. Single organ failure

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

    Rate of single organ failure

  4. Sepsis

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

    Rate of Sepsis

  5. Lung-failure

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

    Rate of Lung-failure

  6. Clinical outcome

    Time frame: At the time point of initial hospital discharge or at death, whichever came first, assessed up to 2 month.

    Clinical outcome according to the Glasgow outcome scale (GOS)

  7. Duration of hospital stay

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

    Duration of hospital stay in days from injury to initial discharge

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 18, 2024
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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