Intramedullary Femoral Reaming, Human Study

Not Applicable

Completed

• Conditions: Organ Failure; Systemic Inflammatory Response Syndrome; Pulmonary Complications

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with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively.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with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively.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

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