Early Fixation versus Conservative therapy of multiple, simple rib fractures (FixCon); a multicenter randomized controlled trial

Early Fixation versus Conservative therapy of multiple, simple rib fractures (FixCon); a multicenter randomized controlled trial - FixCon trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50450

Enrollment

180

Registered

2018-05-18

Start date

2019-01-23

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Rib fracture

Interventions

1) Surgical (intervention) group: - Surgical rib fixation (ORIF) - Pain management - Salbutamol/atrovent inhaler - Oxygen support or mechanical ventilation (if needed) - Pulmonary physical therapy 2)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age 18 years or older 2. For any of the ribs number 4 to 10: A) Three simple fractured ribs of which at least one dislocated over one shaft-width OR B) Three simple fractured ribs with unbearable pain (Visual Analog Scale or Numeric Rating Scale > 6 points) 3. Blunt force trauma 4. Hospital presentation within 72 hours after trauma 5. Provision of informed consent by patient or proxy

Exclusion criteria

Exclusion criteria: 1. Neurotraumatic changes leading to mechanical ventilation (GCS

Design outcomes

Primary

Measure	Time frame
Pneumonia within 30 days after trauma	—

Secondary

Measure	Time frame
Hospital length of stay Need and duration of mechanical ventilation Pain (Numeric Rating Scale, NRS) and analgesics use Quality of life (QoL; Euro-QoL-5D and Short Form-12) (Recovery of) pulmonary function Thoracic injury-related complications and mortality Cost effectiveness	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)