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Intramedullary Femoral Reaming, Human Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01042132
First Posted: January 5, 2010
Last Update Posted: December 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Elisabeth Ellingsen Husebye, Oslo University Hospital
  Purpose
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with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively.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).

Condition Intervention
Pulmonary Complications Organ Failure Systemic Inflammatory Response Syndrome Procedure: the effect of delayed intramedullary reaming Procedure: the reaming of the femoral canal is performed with two different reaming devices

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pathophysiological Effects of- and Inflammatory Response to Intramedullary Femoral Nailing in Patients With Femoral Shaft Fracture

Further study details as provided by Elisabeth Ellingsen Husebye, Oslo University Hospital:

Primary Outcome Measures:
  • cardiopulmonary alterations [ Time Frame: the first three postoperative days ]
  • coagulation, fibrinolytic and cytokine response [ Time Frame: pre-, per- and first 3 days postoperatively ]

Secondary Outcome Measures:
  • fracture healing [ Time Frame: 1 year ]

Enrollment: 17
Study Start Date: May 2003
Study Completion Date: May 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1) IMN and EF/IMN

Two parts of the study are randomized;

1)initial intramedullary reaming and primary external fixation with secondary intramedullary nailing

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.
Active Comparator: 2) TR and RIA
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
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)

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01042132


Locations
Norway
Orthopedic Center, Ullevål University Hopspital
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
Investigators
Study Director: Olav Røise, MD Orthopedic Centre, Ullevaal University Hospital, Oslo, Norway
  More Information

Responsible Party: Elisabeth Ellingsen Husebye, MD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01042132     History of Changes
Other Study ID Numbers: 02066
First Submitted: January 4, 2010
First Posted: January 5, 2010
Last Update Posted: December 1, 2016
Last Verified: April 2002

Keywords provided by Elisabeth Ellingsen Husebye, Oslo University Hospital:
intramedullary reaming
inflammatory response
human
femoral shaft fracture
Reamer-irrigator-aspirator

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock