Session IV - Femur

*A Prospective Randomized Trial Comparing Reamed and Unreamed Intramedullary Nailing: An Analysis of Pulmonary Complications

James N. Powell, MD; The Canadian Orthopaedic Trauma Association, Foothills Medical Centre, Calgary, Alberta, Canada

Introduction: The purpose of this study was to compare the incidence of pulmonary complications in patients with femoral fractures who underwent reamed canal preparation and insertion of an intramedullary nail of 12 mm in diameter with a group that underwent no canal preparation and insertion of an intramedullary nail of <l2mm in diameter. The null hypothesis was that the incidence of pulmonary complications would be no different between the 2 groups.

Methods: The study was a prospective randomized multicenter trial. Patients were determined to be either multiply injured (1SS 18) or to have essentially single limb injury (1SS <18). Patients were then assigned to either the reamed or unreamed category. After the surgical procedure the patients were followed to determine the incidence of pulmonary complications to the time of hospital discharge.

Results: A total of 315 patients have been entered into the study. Of the 315 patients, 147 received a small-diameter nail without canal preparation (unreamed technique). Of these, 101 patients had a single injury with TSS <l8, and 46 patients had a multiple injury with 155 18. A standard diameter nail with reamed preparation of the intramedullary canal was used in 168/315 patients. Of these, 105 patients had a single injury with ISS<18, and 63 patients had a multiple injury with 15518. Age, sex and ISS were similar in the 2 groups. The pulmonary complications were as follows:

		ARDS	Pneumonia	Atelectasis	Fat embolism
Reamed	Single Multiple	1 5	1 10	25 5	8 7
Unreamed	Single Multiple	2 1	3 4	4 14	7 3

The chi square test analysis was performed for all comparisons including a comparison for trend for P <0.05. The results were not statistically significant for each pulmonary complication and for all pulmonary complications combined. A sample size calculation to determine feasibility to continue the study determined that 2000 patients would need to be enrolled to determine whether the trend observed would be significant.

Discussion: The rate of adult respiratory distress syndrome (ARDS) could not be determined to be different using an unreamed intramedullary nail technique (IMN). As such no change from the previous standard of a reamed intramedullary nail in treatment of femoral fixation can be supported by this clinical trial.

Conclusion: We conclude the incidence of pulmonary complications, especially adult respiratory distress syndrome, is no different in either the reamed IMN group or the unreamed IMN group.