Plate Fixation of Distal Femur Fractures: A Protocol for a Study of Two Plate Options

Internal fixation of femur fractures improves alignment and provides stability to the bone
and the surrounding soft tissues. This generally allows for early motion of the adjacent
joints; thus maximizing overall function of the limb. Open reduction and internal fixation
with plates and screws is the standard method that has been used in the treatment of distal
femoral fractures. One common traditional method of internal fixation is the 95-degree angled
blade plate. Recent advances in technology for distal femur fractures include the LCP™
Condylar Plate. This implant differs from the blade plate, because the LCP offers multiple
points of fixed angle contact between the plate and screws in the distal femur. The
introduction of plates with the option of locked screws has provided means to increase the
rigidity of fixation in osteoporotic bone or in periarticular fractures with a small distal
segment, and the LCP may be technically easier to apply than the blade plate. To the
investigators' knowledge, there have been no published clinical or biomechanical studies
specific to the LCP Condylar Plate, although the early results of LCP implants for other
fractures are promising. The investigators believe that locked plating represents a valuable
advancement in fracture treatment. However, the limitations of this new technology and the
indications for its use have not been completely elucidated. Furthermore, the cost of the new
technology is approximately seven times more than the traditional treatment. This is a
randomized, prospective, multi-center study to compare the blade plate and the LCP in the
distal femur. All patients 16 years of age or older, regardless of race or gender, with a
supracondylar fracture of distal femur will be considered. Whether patients are treated with
a blade plate or/and LCP, they will be receiving standard orthopedic care for their injury.
Neither of these methods currently places a patient at increased surgical or post-surgical
risk for problems with infection, nonunion, malunion, or other complications. Because of the
study, early and late complication rates and functional outcomes after these treatments may
be better defined, allowing for optimization of care of people with these injuries in the
future. This should reduce not only direct and indirect costs to the individual, but also
costs to society.