Organ Failure, Pulmonary Complications, Systemic Inflammatory Response Syndrome
Conditions
Keywords
intramedullary reaming, inflammatory response, human, femoral shaft fracture, Reamer-irrigator-aspirator
Brief summary
To what extent the cardiopulmonary and inflammatory response is affected by initial femoral intramedullary nailing in the already traumatized and inflammatory activated patient was analyzed in the present study with the attention to survey the additional burden of this operative treatment. The patients are monitored with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively. The study is partly randomized 1)where delayed intramedullary nailing is compared with primary nailing of the femur, and 2) a new reaming technique (RIA) is compared with a standard reaming technique (TR).
Detailed description
To what extent the cardiopulmonary and inflammatory response is affected by initial femoral intramedullary nailing in the already traumatized and inflammatory activated patient was analyzed in the present study with the attention to survey the additional burden of this operative treatment. The patients are monitored with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively. The study is partly randomized 1)where delayed intramedullary nailing is compared with primary nailing of the femur, and 2) a new reaming technique (RIA) is compared with a standard reaming technique (TR).
Interventions
PROCEDUREthe effect of delayed intramedullary reaming
in one group intramedullary reaming and nailing is performed immediately, femoral fractures in the second group are external fixated and than secondary nailed.
PROCEDUREthe reaming of the femoral canal is performed with two different reaming devices
the reaming of the femoral canal is performed with two different reaming devices; a traditional reamer (TR)and the reamer-irrigator-aspirator (RIA)
Sponsors
Ullevaal University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* femoral shaft fracture suitable for intramedullary nailing * \< 24 hours postinjury
Exclusion criteria
* previous fracture of the femur * pathological fracture * femur deformities * pregnancy * previous intramedullary nailing or external fixation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cardiopulmonary alterations | the first three postoperative days |
| coagulation, fibrinolytic and cytokine response | pre-, per- and first 3 days postoperatively |
Secondary
| Measure | Time frame |
|---|---|
| fracture healing | 1 year |
Countries
Norway
Outcome results
None listed