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A multicenter randomised study in which operative stabilization of rib fractures with a flail chest is compared with mechanical ventilation.

A multicenter randomised study in which operative stabilization of rib fractures with a flail chest is compared with mechanical ventilation. - OPVENT

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37982
Enrollment
140
Registered
2012-02-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

multiple rib fractures Unstable chest

Interventions

Surgical stabilization of the fractured ribs, by means of special osteosynthesis plates. the implanted material is the Matrix rib Stabilization kit manufactured by Synthes *

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. age > 17 jr. 2. Flail chest

Exclusion criteria

Exclusion criteria: 1. non traumatic rib fractures 2. prior thoracotomy 3. Allergy for Titanium 4. Missing informed consent

Design outcomes

Primary

MeasureTime frame
Primary outcome: Will ORIF of rib fractures with a flail chest in comparison to non-operative treatment lead to less pneumonia.—

Secondary

MeasureTime frame
Secondary questions: * Will surgical treatment of rib fractures with a flail in comparison to non-operative treatment result in a shorter duration of artificial respiration? * Will the surgical treatment of rib fractures with a flail in comparison to non-operative treatment result in a shorter IC stay? * Will the surgical treatment of rib fractures with a flail in comparison to non-operative treatment result in a shorter hospital stay? * Will the surgical treatment of rib fractures with a flail in comparison to non-operative treatment result in a faster or better reduction of pain. * Is surgical treatment of rib fractures with a flail in comparison to non-operative treatment more cost effective.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)