NCT01042132

Intramedullary Femoral Reaming, Human Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Ullevaal University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively.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with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively.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

Conditions

• Pulmonary Complications
• Organ Failure
• Systemic Inflammatory Response Syndrome

Interventions

Type	Name	Description
PROCEDURE	the 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.
PROCEDURE	the 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)

Timeline

• Start date: 2003-05-01
• Primary completion: 2011-10-01
• Completion: 2012-05-01
• First posted: 2010-01-05
• Last updated: 2016-12-01

Locations

1 site across 1 country: Norway