Intramedullary Femoral Reaming, Human Study

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01042132
• Date of registration: 04/01/2010
• Primary sponsor: Ullevaal University Hospital
• Public title: Intramedullary Femoral Reaming, Human Study
• Scientific title: Pathophysiological Effects of- and Inflammatory Response to Intramedullary Femoral Nailing in Patients With Femoral Shaft Fracture
• Date of first enrolment: May 2003
• Target sample size: 36
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01042132
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

Norway

Contacts

• Name: Olav Røise, MD
• Affiliation: Orthopedic Centre, Ullevaal University Hospital, Oslo, Norway

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Organ Failure

Pulmonary Complications

Systemic Inflammatory Response Syndrome

Intervention(s)

Procedure: the effect of delayed intramedullary reaming

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

Primary Outcome(s)

cardiopulmonary alterations [Time Frame: the first three postoperative days]

coagulation, fibrinolytic and cytokine response [Time Frame: pre-, per- and first 3 days postoperatively]

Secondary Outcome(s)

fracture healing [Time Frame: 1 year]

Secondary ID(s)

02066

Source(s) of Monetary Support

Please refer to primary and secondary sponsors