Session III - Hip / Femur
Fri., 10/11/13 Hip/Femur, PAPER #51, 10:50 am OTA 2013
A Prospective Randomized Control Trial of Fixation of Intertrochanteric Fractures: Compression Hip Screw Versus Third Generation Long Cephalomedullary Nail
Cameron Cooke, MD; Diana Kennedy, MBBS; Doug King, FRACS (ortho);
Mark Dekkers, FRACS (ortho);
Princess Alexandra Hospital, Brisbane, Queensland, Australia
Purpose: This study evaluates the clinical outcomes of patients with intertrochanteric fractures treated with dynamic hip compression devices versus third generation long cephalomedullary nails. The hypothesis was that there is no difference in failure rate between the two devices.
Methods: This is a prospective, randomized control trial of fixation of intertrochanteric fractures comparing the Intramedullary Hip Screw (IMHS) and Dynamic Hip Screw (DHS) (Smith & Nephew). Between 2007 and 2010, there were 232 patients (68 males, 164 females) randomized into two equal groups at the Princess Alexandra Hospital. Inclusion criteria were: (1) patient age greater than 60 years, (2) patient had sustained an intertrochanteric femoral fracture, and (3) consent was attained for their randomization and inclusion in the trial. Exclusion criteria for this trial were: (1) multitrauma patients, (2) patient age less than 60, (3) subcapital fractures, (4) subtrochanteric fractures, (5) concomitant femoral shaft fracture, and (6) preexisting distal metalware or malunion precluding the use of a long nail. Each patient was followed up at 3 months and 1 year postoperatively. The primary outcome measures were failure of fixation and the need for reoperation. Secondary outcome measures included intraoperative measures (procedure time, operator, tip-to-apex distance), perioperative measures (hemoglobin levels and transfusion requirements), and postoperative functional outcomes.
Results: The mean age of the total group was 79.5 years. Fractures were divided into stable (n = 109) versus unstable fractures (n = 125). Average operative times were 51 minutes for DHS and 72 minutes for IMHS (P ≤0.001). Tip-to-apex distance was independent of type of fracture or level of surgical expertise (consultant versus registrar) (P ≤0.0001). Fixation failures were observed in 7of 116 patients in the DHS group and 3 of 116 in the IMHS group. Of the 7 fixation failures in the DHS group, 3 were in patients’ unstable fractures. Of the 3 failures in the IMHS group, 2 were in patients with unstable fractures. There were 7 revisions in total, 4 in the DHS fixation failure group versus 3 in the IMHS fixation failure group. 49% of patients had a drop of hemoglobin postoperatively and required postoperative blood transfusion (43 DHS, 71 IMHS). Unstable fractures with IMHS had the highest rates of transfusion (P ≤0.002). Mortality rate was 21% at 3 months and 26% at 12 months.
Conclusion: This study did not find a significant difference in fixation failures when comparing DHS and IMHS in patients with intertrochanteric fractures. It also found that DHS has a shorter operating time, independent of operator, and that unstable fractures fixed with IMHS have the highest rates of requiring blood transfusion postoperatively.
Alphabetical Disclosure Listing
• The FDA has not cleared this drug and/or medical device for the use described in this presentation (i.e., the drug or medical device is being discussed for an “off label” use). ◆FDA information not available at time of printing. Δ OTA Grant.