Session V - Femur

A Prospective Randomized Clinical Trial Comparing Reamed versus Unreamed Intramedullary Nailing of Femoral Shaft Fractures: Assessment of Pulmonary Dysfunction

Russell DeGroote, MD; James Powell, MD; Richard Buckley, MD, University of Calgary, Calgary, AB, Canada; Robert Fiebel, MD, University of Ottawa, Ottawa, ON, Canada, Ross Leighton, MD, Dalhousie University, Halifax, NS, Canada; Jim McCormack, MD, University of British Columbia, Vancouver, BC, Canada; Emil Schemitsch, MD, David Stephen, MD, University of Toronto, Toronto, ON, Canada

The objective of this clinical trial was to determine if the type of intramedullary nail fixation (IMN) in acute femoral shaft fractures affects pulmonary function.

This study was a prospective randomized clinical trial, taking place in tertiary care centres in multiple Canadian cities.

Patients presenting with an acute femoral shaft fracture were stratified according to injury patterns into either isolated femoral shaft fractures or multiply-injured femoral shaft fracture groups. Within each strata the patients were randomized into two groups. Group one consisted of those individuals with an acute femoral shaft fracture who received an intramedullary nail utilizing a reamed technique. Group two consisted of those individuals with an acute femoral shaft fracture who received an intramedullary nail without a reaming technique.

Serial PaO2 : FiO2 ratios were taken at specific times. These times were: 1. Pre-op 2. One hour post-op 3. Day one post-op 4. Day two post-op 5. Day three post-op, using serial blood gases. Pulmonary function was divided into three categories; a normal group with a ratio of greater than 250; a pulmonary dysfunction group with a ratio of 151-250; and a critically hypoxemic group with a ratio of less than 150. Intraoperatively, patients were ventilated to a standardized end-tidal CO² and drops in Pet CO² are recorded after guide-wire/reamer and nail insertion.

To date, 235 patients have been recruited into the study over a twenty-four month period, with 153 charts available for interim descriptive analysis. After stratification on injury status, there were 94 patients with an isolated femur fracture and 59 patients with a femur fracture associated with multiple injuries.

Descriptive analysis of the data shows that in the isolated femur group, 49 patients were randomized to the unreamed technique for nail insertion and 45 patients received the reamed technique for nail insertion. In the multiply injured group, 27 patients were randomized to the unreamed technique for nail insertion and 32 patients received the reamed technique for nail insertion. There were 15 patients in the unreamed group and 22 in the reamed group that met our criteria of a pulmonary contusion.

The median isolated femur ISS scores were 9 (range 9-17) in the unreamed group and 9 (range 9-14) in the reamed group. In the multiply injured group, the ISS scores were 26 (range 18 - 45) for the unreamed group and 26 (range 18 - 35) for the reamed group.

The median surgical time in the unreamed femur fracture group was 94 minutes and 116 minutes in the reamed femur fracture group.

With regards to pulmonary function, the two groups of patients behave differently over this time period (p0.05), and as such must be analyzed separately. In the isolated injury strata, both the reamed and unreamed techniques showed similar decreases and recovery of the PaO2 : FiO2 ratios over the defined time period. While in the multiply injured strata, there is a tendency in the reamed technique group to maintain lower PaO2: FiO2 ratios than in the unreamed group over the same time period.

When the patient populations are combined for injury status, there are no cases of ARDS, no cases of PE, one case of FES, four cases of pneumonia, and ten cases of atelectasis in the unreamed technique group. In the reamed group there are 5 cases of ARDS, 2 cases of FES, no cases of PE, 7 cases of pneumonia, and ten cases of atelectasis.

The above descriptive analysis suggests that reamed intramedullary nailing of acute femoral shaft fractures in the multiply injured patient may suppress pulmonary function using the PaO2 : FiO2 ratio in the defined time interval. In the isolated femoral shaft fracture group there appears to be no difference in the technique used with regards to pulmonary function in this specific time interval. There also appears to be more cases of pulmonary morbidity in the reamed technique group.