Status:
UNKNOWN
The FLiP Study, a Pilot Cluster Randomized Trial
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Hamilton Academic Health Sciences Organization
Conditions:
Femur Fracture
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary objective of this pilot trial is to assess the feasibility of a definitive trial to determine the effect of lateral patient positioning versus supine positioning with fracture table use fo...
Detailed Description
Femoral shaft fractures typically occur alongside other complex, high-energy injuries in the poly-traumatized patient. Femur fractures can cause extensive bleeding and surrounding muscle injury, and h...
Eligibility Criteria
Inclusion
- Adult aged 18 years or older
- Mid shaft (Diaphyseal) femur fracture appropriate for antegrade fixation
- Surgery performed by participating surgeon or delegate
- Provision of informed consent
- Enrolled within 3 weeks of femoral shaft fixation
Exclusion
- • 1. Ipsilateral tibial fracture 2. Bilateral femur fracture 3. Ipsilateral femoral neck fracture 4. Ipsilateral acetabular fracture 5. Periprosthetic fracture 6. Pathologic fracture 7. Previous external fixation of femoral shaft fracture 8. Inability to be positioned in lateral decubitus because of a concomitant injury 9. Pregnancy (due to decubitus positioning) 10. Incarceration 11. Expected injury survival of less than 6 months 12. Terminal illness with expected survival of less than 6 months (expected follow up of study) 13. Inability to provide informed consent (e.g. cognitive disability, language barrier, significant delirium or dementia) 14. Currently involved in study that does not permit co-enrolment 15. Likely problems, in the judgment of study personnel, with maintaining follow-up with the patient
Key Trial Info
Start Date :
October 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03868280
Start Date
October 16 2020
End Date
June 1 2023
Last Update
July 28 2021
Active Locations (3)
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1
McMaster University
Hamilton, Ontario, Canada
2
Ottawa Civic Hospital
Ottawa, Ontario, Canada
3
Vall d'Hebron University Hospital
Barcelona, Spain