search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


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


- candidate number28971
- NTR NumberNTR7248
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-mei-2018
- Secondary IDsMEC-2018-067 (METC Erasmus MC) NL63430.078.17
- Public TitleEarly Fixation versus Conservative therapy of multiple, simple rib fractures (FixCon); a multicenter randomized controlled trial
- Scientific TitleEarly Fixation versus Conservative therapy of multiple, simple rib fractures (FixCon); a multicenter randomized controlled trial
- ACRONYMFixCon
- hypothesisOpen reduction and internal fixation of multiple simple fractured ribs will result in less pneumoniae, hospital stay, and work absence, and hence will be more cost-effective than nonoperative treatment.
- Healt Condition(s) or Problem(s) studiedRib fractures
- Inclusion criteria1. 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 criteria1. 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. 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2019
- planned closingdate31-dec-2022
- Target number of participants180
- InterventionsPatients 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 mechanical ventilation, and pulmonary physical therapy will be given.
The control group will receive nonoperative treatment, aimed at complication prevention and comfort, consisting of pain and inhalation medication, oxygen therapy or mechanical ventilation if needed, and pulmonary physical therapy
- Primary outcomePneumonia <30 days after trauma
- Secondary outcomeHospital 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.
- TimepointsDaily during hospital admission, at 14 and 30 days, and at three six, and 12 months after trauma.
- Trial web siteNone.
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES M.M.E. Wijffels
- CONTACT for SCIENTIFIC QUERIES M.M.E. Wijffels
- Sponsor/Initiator Erasmus Medical Center, Department of Surgery, Erasmus MC, Trauma Research Unit department of Surgery
- Funding
(Source(s) of Monetary or Material Support)
Stichting Coolsingel, Osteosynthesis and Trauma Care Foundation (OTCF)
- PublicationsNone yet; study is ongoing
- Brief summaryBACKGROUND
Surgical fixation of multiple rib fractures, resulting in a flail chest, is beneficial compared with nonoperative treatment regarding, among others, rate of pneumonia, duration of mechanical ventilation and hospital stay. Analogous to this fact, the optimal treatment for multiple single fractured rib fractures may be surgical as well. If this is true, however, remains unknown since no randomized studies are available on this subject.

AIM
The primary aim of this study is to examine the effect of open reduction and internal fixation (ORIF) versus nonoperative treatment of multiple simple fractured ribs on the rate of pneumonia within 30 days after trauma, in adult patients who sustained multiple simple fractured ribs.
The secondary aims are to examine in these patients:
1) the effect of ORIF versus nonoperative treatment on the need for and duration of mechanical ventilation,
2) the effect of ORIF versus nonoperative treatment on the level of pain and analgesics use
3) the effect of ORIF versus nonoperative treatment on the (recovery of) pulmonary function
4) the effect of ORIF versus nonoperative treatment on the hospital and ICU length of stay
5) the effect of ORIF versus nonoperative treatment on the rate of thoracic injury-related complications and mortality
6) the effect of ORIF versus nonoperative treatment on the quality of life
7) the effect of ORIF versus nonoperative treatment on the total costs (in-hospital and socio-economic) of treatment, health care consumption, and work absence.

STUDY DESIGN
Multicenter Randomized Controlled Trial (RCT)

POPULATION
Adult patients with three or more simple fractured ribs.

INTERVENTION
Patients will be equally randomized to two groups:
1) Open reduction and internal fixation (ORIF)
2) Nonoperative treatment

ENDPOINTS
Primary outcome measure: pneumonia within 30 days
Secondary outcome measures: mechanical ventilation; pulmonary function; hospital stay; complications and mortality; quality of life (EQ-5D; health care consumption; and direct and indirect medical costs.
Data will be collected daily during hospital admission, at 14 and 30 days, and at three six, and 12 months after trauma.

RECRUITING COUNTRIES
The Netherlands
- Main changes (audit trail)
- RECORD31-mei-2018 - 10-jun-2018


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl