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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29375
Enrollment
180
Registered
2018-05-31
Start date
2019-01-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Multiple, simple rib fractures

Interventions

Patients in the intervention group will be treated with open reduction and internal fixaton of fractured ribs with the Matrix Rib System. If needed, pain and inhalation medication, oxygen therapy or m

Sponsors

Erasmus MC, University Medical Center Rotterdam, Trauma Research Unit, Department of Surgery
Lead Sponsor

Eligibility

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 ¡Ü8 at 48hrs post injury. If unable to assess full GCS due to intubation or other causes, GCS motor ¡Ü 4 at 48 hours post injury) 2. Rib fractures due to cardioplulmonary 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

Design outcomes

Primary

MeasureTime frame
Pneumonia <30 days after trauma

Secondary

MeasureTime 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; and cost effectiveness.

Contacts

Public ContactM.M.E. Wijffels

P.O. Box 2040, 3000 CA Rotterdam

m.wijffels@erasmusmc.nl+31-10 7031050

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)