Overview

This trial has been completed.

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 17 participants
Trial identifier NCT01042132, 02066

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with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively.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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
Two parts of the study are randomized; 1)initial intramedullary reaming and primary external fixation with secondary intramedullary nailing
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.
(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
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)

Primary Outcomes

Measure
cardiopulmonary alterations
time frame: the first three postoperative days
coagulation, fibrinolytic and cytokine response
time frame: pre-, per- and first 3 days postoperatively

Secondary Outcomes

Measure
fracture healing
time frame: 1 year

Eligibility Criteria

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

Additional Information

Official title Pathophysiological Effects of- and Inflammatory Response to Intramedullary Femoral Nailing in Patients With Femoral Shaft Fracture
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).
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Oslo University Hospital.