Intramedullary Femoral Reaming, Human Study

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with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively.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with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively.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

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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