Intertrochanteric Femur Fractures Clinical Trial
Official title:
Computer-Assisted Navigation for Intramedullary Nail Fixation of Intertrochanteric Femur Fractures
There are approximately 250,000 hip fractures in the US every year, and intertrochanteric
(IT) fractures (fractures that occur just below the femoral head) account for nearly half of
these fractures. The use of intramedullary (IM) nails for fixation of IT femur fractures has
become a well-accepted and increasingly more common procedure among orthopaedic
traumatologists, and is standard of care at our institution.
While advancements in intramedullary nail fixation have made it a relatively efficient
procedure, the placement of the lag screw into the femoral head still remains a challenging
step in the procedure. Inaccurate placement can lead to screw cut-out, one of the most
commonly reported complications with IM nail fixation. Previous work has shown that the lag
screw position is an important factor in reducing screw cut-out. This step of the procedure
can be time demanding and often requires several intraoperative radiographs for accurate
placement. Recently developed computer-assisted navigation systems provide surgeons with the
ability to track screw placement in real-time. This could allow for improved screw placement
and potentially reduce radiation exposure to the patient and surgeon. To date, the potential
advantages of computer-assisted navigation have not been examined.
The primary objective of this study is to examine whether the use of Stryker's ADAPT
computer-assisted navigation for Gamma nail fixation can result in improved lag screw
placement. The secondary objective is to examine whether the use of the ADAPT for Gamma nail
fixation can reduce intraoperative radiation exposure.Our hypothesis is that there is a
difference in the lag screw placement (i.e. tip to apex distance measurement) between
procedures using the ADAPT system versus the conventional technique for Gamma nail fixation.
Additionally, we hypothesize that there is a difference in radiation exposure (i.e.
fluoroscopy time) between procedures using the ADAPT system versus the conventional
technique for Gamma nail fixation.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment