Intramedullary Femoral Reaming, Human Study

Not Applicable

Completed

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

• Registration Number: NCT01042132
• Lead Sponsor: Ullevaal University Hospital

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with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively.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

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with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively.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

Study Timeline

• Status Verified: 2002-04
• Study Start: 2003-05
• Study First Submitted: 2010-01-04
• Study First Submitted QC: 2010-01-04
• Study First Posted: 2010-01-05
• Primary Completion: 2011-10
• Study Completion: 2012-05
• Last Update Submitted: 2016-11-30
• Last Update Posted: 2016-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
cardiopulmonary alterations	the first three postoperative days
coagulation, fibrinolytic and cytokine response	pre-, per- and first 3 days postoperatively

Secondary Outcome Measures

Name	Time	Method
fracture healing	1 year

Trial Locations

Locations (1)

Orthopedic Center, Ullevål University Hopspital; 🇳🇴 Oslo, Norway