Intramedullary Femoral Reaming, Human Study

U

Ullevaal University Hospital

Status

Completed

Conditions

Systemic Inflammatory Response Syndrome
Organ Failure
Pulmonary Complications

Treatments

Procedure: the reaming of the femoral canal is performed with two different reaming devices
Procedure: the effect of delayed intramedullary reaming

Study type

Interventional

Funder types

Other

Identifiers

NCT01042132
02066

Details and patient eligibility

About

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with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively.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

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with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively.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

Enrollment

17 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

17 participants in 2 patient groups

1) IMN and EF/IMN
Active Comparator group
Description:
Two parts of the study are randomized; 1)initial intramedullary reaming and primary external fixation with secondary intramedullary nailing
Treatment:
Procedure: the effect of delayed intramedullary reaming
2) TR and RIA
Active Comparator group
Description:
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
Treatment:
Procedure: the reaming of the femoral canal is performed with two different reaming devices

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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