Intramedullary Femoral Reaming, Human Study

Systemic Inflammatory Response Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01042132
• Other study ID #: 02066
• 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with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively.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with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively.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

• Organ Failure
• Pulmonary Complications
• Systemic Inflammatory Response Syndrome

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