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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with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively.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).
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with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively.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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1) IMN and EF/IMN | Active Comparator | Two parts of the study are randomized; 1)initial intramedullary reaming and primary external fixation with secondary intramedullary nailing |
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| 2) TR and RIA | Active Comparator | Two parts of the study are randomized; 2)traditional reaming (TR)is compared to a new reaming device, RIA, which is a reamer connected to suction and flushing for prevention of increased intramedullary pressure |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the effect of delayed intramedullary reaming | Procedure | in one group intramedullary reaming and nailing is performed immediately, femoral fractures in the second group are external fixated and than secondary nailed. |
| Measure | Description | Time Frame |
|---|---|---|
| cardiopulmonary alterations | the first three postoperative days | |
| coagulation, fibrinolytic and cytokine response | pre-, per- and first 3 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| fracture healing | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olav Røise, MD | Orthopedic Centre, Ullevaal University Hospital, Oslo, Norway | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopedic Center, Ullevål University Hopspital | Oslo | 0407 | Norway |
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| ID | Term |
|---|---|
| D018746 | Systemic Inflammatory Response Syndrome |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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| the reaming of the femoral canal is performed with two different reaming devices | Procedure | the reaming of the femoral canal is performed with two different reaming devices; a traditional reamer (TR)and the reamer-irrigator-aspirator (RIA) |
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