Intramedullary Femoral Reaming, Human Study
This trial is active, not recruiting.
|Conditions||pulmonary complications, organ failure, systemic inflammatory response syndrome|
|Treatments||the effect of delayed intramedullary reaming, the reaming of the femoral canal is performed with two different reaming devices|
|Sponsor||Ullevaal University Hospital|
|Start date||May 2003|
|End date||October 2011|
|Trial size||36 participants|
|Trial identifier||NCT01042132, 02066|
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with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively.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).
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
time frame: the first three postoperative days
coagulation, fibrinolytic and cytokine response
time frame: pre-, per- and first 3 days postoperatively
time frame: 1 year
Male or female participants from 18 years up to 65 years old.
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
|Official title||Pathophysiological Effects of- and Inflammatory Response to Intramedullary Femoral Nailing in Patients With Femoral Shaft Fracture|
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