Fri., 10/15/10 Knee, Tibia & Pediatrics, Paper #59, 4:10 pm OTA-2010
A Multicenter Prospective Randomized Trial Comparing the Less Invasive Stabilization System (LISS) and Mini-Invasive Dynamic Condylar System (DCS) (FDA=Non-U.S. research conducted within guidelines of my country)
Abdullah A. Hawsawi, MD1; Ross K. Leighton, MD1; Richard A. Preiss, MD1; COTS Group2;
Kelly Trask, PhD, RC1;
1Queen Elizabeth II & Health Science Center, Dalhousie University,
Halifax, Nova Scotia, Canada;
2Multiple Canadian Orthopaedic Trauma Society Centers in Canada:
Toronto and London, Ontario; Calgary, Alberta; Vancouver, British Columbia
Background: Surgical fixation of distal femoral fractures has been associated with nonunion and varus collapse. The soft-tissue stripping associated with this fracture and the surgical approach have been factors associated with delayed union and infection. The limited softtissue exposure has been lauded as a solution to this fracture. However, it has occurred with new fixation as well. This study is an attempt to look at the fixation. Does the LISS system improve the results of this difficult fracture? Is there truly a difference in the outcome of this fracture utilizing the locked plate system or is the perceived difference due to the surgical mini-invasive approach.
Methods: 140 patients were screened and only 60 were randomized and treated in 8 academic centers over 5 years. All C3 fractures were excluded as they were felt not to be treatable by the DCS device. 40 females and 27 males were included in the study at the beginning and randomized appropriately. Thirteen patients were excluded later during the evaluation, as they were C3 fractures. They were followed with intent to treat, and all but one went on to union.
Results: 53 patients were randomized: 28 had the LISS implant, and 25 had the DCS utilized. There were three nonunions in the LISS group plus two early cases requiring further surgery to correct an early malreduction on day 2 to 5 postsurgery. Furthermore, one patient developed a knee arthrofibrosis that required arthroscopic joint release with subsequent implant failure. That necessitated a reoperation. This translated into a reoperation rate of 21% in the LISS group compared to 4% in the DCS.
Conclusion: This prospective multicenter trial showed a significant difference when comparing the LISS to the DCS system in a minimally invasive approach of distal femur fracture fixation.
Alphabetical Disclosure Listing (292K PDF)
• 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.