Intramedullary Femoral Reaming, Human Study

Study Overview
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Brief Summary
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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with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively.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).

Detailed Description
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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with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively.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).

Official Title
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Pathophysiological Effects of- and Inflammatory Response to Intramedullary Femoral Nailing in Patients With Femoral Shaft Fracture

Conditions
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Pulmonary Complications, Organ Failure, Systemic Inflammatory Response Syndrome

Intervention / Treatment
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* Procedure: the effect of delayed intramedullary reaming
* Procedure: the reaming of the femoral canal is performed with two different reaming devices


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1) IMN and EF/IMN<br>Two parts of the study are randomized; 1)initial intramedullary reaming and primary external fixation with secondary intramedullary nailing | Procedure: the effect of delayed intramedullary reaming<br>* in one group intramedullary reaming and nailing is performed immediately, femoral fractures in the second group are external fixated and than secondary nailed.<br>|
| Active Comparator: 2) TR and RIA<br>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 | Procedure: the reaming of the femoral canal is performed with two different reaming devices<br>* the reaming of the femoral canal is performed with two different reaming devices; a traditional reamer (TR)and the reamer-irrigator-aspirator (RIA)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiopulmonary alterations |  | the first three postoperative days | 
| coagulation, fibrinolytic and cytokine response |  | pre-, per- and first 3 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fracture healing |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intramedullary reaming, inflammatory response, human, femoral shaft fracture, Reamer-irrigator-aspirator