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Completed

NCT Number: NCT01042132

Intramedullary Femoral Reaming, Human Study

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with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively.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

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Key information

Conditions

Pulmonary Complications Inflammation Organ Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Systemic Inflammatory Response Syndrome

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopedic Center, Ullevål University Hopspital

Oslo, 0407, Norway

About this study

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with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

the effect of delayed intramedullary reaming

Procedure

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

Procedure

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

  1. cardiopulmonary alterations

    Time frame: the first three postoperative days

  2. coagulation, fibrinolytic and cytokine response

    Time frame: pre-, per- and first 3 days postoperatively

Secondary outcomes

  1. fracture healing

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Ullevaal University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2011
Study completion
2012
First posted
Jan 5, 2010
Registry last updated
Dec 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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