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

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 180

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

1. Neurotraumatic changes leading to mechanical ventilation (GCS <= 8 at 48hrs
post injury. If unable to assess full GCS due to intubation or other causes,
GCS motor <= 4 at 48 hours post injury)
2. Ribfractures after cardiopulmonary resuscitation
3. Surgical rib fixation not possible due to additional traumatic injuries
(hemodynamically or pulmonary unstable, for example based on parenchymal lung
trauma) or patient is unfit for surgery; to be decided by an ICU-doctor, trauma
surgeon, or anesthesiologist
4. Flail chest, based on radiological or clinical findings
5. Decreased sensory or motor function due to (previous) cervical or thoracic
spine failure
6. Previous rib fractures or pulmonary problems, requiring continuous oxygen
use at home pre-trauma
7. Congenital thoracic deformity (pectus excavatum, pectus carinatum, severe
scoliosis or kyphosus)
8. Inhalation trauma or severe burns close to or inside mouth or neck
9. Surgical fixation of the ribs not feasible within seven days after trauma
10. Patients unwilling or unable to comply with the intervention or follow-up
visit schedule
11. Insufficient comprehension of Dutch language to understand rehabilitation
programs and other treatment information in the judgment of the attending
physician
12. Participation in another surgical intervention or drug study that might
influence any of the outcome parameters

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pneumonia within 30 days after trauma</p><br>

Secondary Outcome Measures

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

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