Improvements are needed in hip fracture fixation.

The objective of internal fixation of hip fractures is anatomic reduction, stable internal fixation, early patient mobilization and return to function.

Challenges:

10% to 12% of all hip fractures (more than 70,000 patients globally) fixed with the current static nail designs are not anatomically re-aligned during surgical fixation. Varus malreduction is the most common problem with fixation of hip fractures and occurs when the fracture is repaired in a shortened and more horizontal manner.

Difficulty with intraoperative techniques or the nail selection for each patient’s anatomy can cause varus. Static nails, which have one lag screw-to-nail angle, must be revised after implantation when the fracture is not positioned correctly. Malalignment may result in a poor clinical outcome. With current static implants, the surgeon cannot move the fractured bone of the proximal femur to the correct position after the nail has been inserted (called the “in situ reduction”). In addition, manufacturers and distributors are required to support a large inventory that is mostly unused in order to accommodate for anatomical differences between patients.

The EPIX VAN™ System – Simplified, Intuitive Instrumentation:

Solution:

The EPIX VAN™ System functions and is designed to solve all of these challenges. It is the only patient-specific variable angle nail.

Challenge 1: Varus Malreductions

Varus malreduction may cause a short leg, pain, and limp.There is an increased risk of cutout, hardware failure and need for revision surgery.

What is the current solution after fracture fixation failure? Most commonly the patient is treated with a reconstruction or hip replacement. The physical, emotional and financial cost to the patient and society is significant.

Solution: The EPIX VAN System is an implant and reduction tool that may solve varus malreductions consistently and with minimal change in surgical workflow.

Challenge 2: Center-Center Positioning of Lag Screw May be Difficult.

If the center-center position of the lag screw can not be achieved, there is an increase in lag screw to bone interface failure (cutout). This causes pain and may lead to a hip replacement.

Solution: The EPIX VAN System gives the surgeon freedom to infinitely adjust guide wire placement into the center-center position in the femoral head. The surgeon can chose the angle of the guide wire and lag screw that will place the implant in the perfect position every time.

Challenge 3: Nail Prominence

Nail prominence may cause lateral hip pain.

Solution: The EPIX VAN System gives the surgeon the freedom to increase the angle between the lag screw and the nail up to 140 degrees, which moves the nail deeper into the bone proximally. This eliminates nail prominence.

This large inventory is expensive to manufacture, maintain and store. Selecting the correct nail for each individual patient is made in a quickly changing surgical environment.

Solution: The EPIX VAN System is adjustable and therefore increases manufacturer efficiency and decreases on-shelf unused inventory to 55 nails. This may decrease the overall healthcare costs. If the short (205mm) nail is chosen, the inventory size decreases to one (1) nail.

EPIX VAN™ is the Only Patient-Specific Variable Angle Nail.

EPIX System gives the surgeon freedom to infinitely adjust guidewire placement into the center-center position in the femoral head. EPIX VAN enables in situ movement of the lag screw to achieve anatomic reduction of the fracture. This may improve patient outcomes by avoiding varus, cutout, and hardware failure.