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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01042132
Other study ID # 02066
Secondary ID
Status Completed
Phase N/A
First received January 4, 2010
Last updated November 30, 2016
Start date May 2003
Est. completion date May 2012

Study information

Verified date April 2002
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway: Ethics Committee
Study type Interventional

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with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively.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


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with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively.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


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date May 2012
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
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)

Locations

Country Name City State
Norway Orthopedic Center, Ullevål University Hopspital Oslo

Sponsors (1)

Lead Sponsor Collaborator
Ullevaal University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary cardiopulmonary alterations the first three postoperative days No
Primary coagulation, fibrinolytic and cytokine response pre-, per- and first 3 days postoperatively No
Secondary fracture healing 1 year No
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