Market Overview

Newly Published Data Demonstrate Bone In-Growth Potential of Stryker's 3D-Printed Tritanium® Cage

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- Comparative animal study found significant differences in
biomechanical and histologic performance among various interbody cage
materials

- Results showed that Stryker's 3D-printed porous Tritanium cages
achieved statistically significant increases in bone in-growth

Stryker's Spine division today announced the publication of a
pre-clinical animal study comparing the performance of spinal implants
made from a variety of materials, which illustrated the bone in-growth
and biological fixation capabilities of its 3D-printed Tritanium cages.
The study was published in the July issue of The Spine Journal.

The purpose of the study was to compare the bone in-growth and
biomechanical differences of interbody cages with various material
technologies in an ovine lumbar interbody fusion model. The cages
involved in this study included traditional PEEK cages, plasma-sprayed
titanium-coated PEEK cages, and Stryker's 3D-printed porous Tritanium
cages.1

The results demonstrated that the Tritanium cages exhibited
significantly greater total bone volume within the graft window at both
8 and 16 weeks compared to the PEEK cages (p<0.01).1 Tritanium
cages also were the only cages that showed a decrease in range of motion
and an increase in stiffness across all three loading directions (axial
rotation, flexion-extension, and lateral bending) between the 8-week and
16-week time points (p-value ≤0.01). 1

"The results of this study provide an evidence-based approach to
decision-making regarding interbody materials for spinal fusion, as
there is significant variability in the materials commonly used for
interbody cages in spine surgery," said Sigurd H. Berven, M.D.,
orthopaedic surgeon at the University of California, San Francisco. "The
study showed the potential for bone in-growth into and around the
Tritanium cages."

According to Michael Carter, vice president and general manager of
Stryker's Spine division, 3D printing, also known as additive
manufacturing, allows the creation of a material with "precisely
randomized"2 porous structures designed to mimic bone.2
"Stryker's proprietary Tritanium Technology, a novel, highly porous
titanium alloy material designed for bone in-growth and biological
fixation, is based on additive manufacturing techniques for orthopaedic
surgery pioneered by Stryker over 15 years ago," Carter said. "This
important study reinforces the value of our growing line of Tritanium
interbody cages and demonstrates Stryker's commitment to bringing the
latest in advanced technologies to our customers."

The study titled "Bony Ingrowth Potential of 3D Printed Porous Titanium
Alloy: A Direct Comparison of Interbody Cage Materials in an In Vivo
Ovine Lumbar Fusion Model," can be accessed here.

About Stryker

Stryker is one of the world's leading medical technology companies and,
together with its customers, is driven to make healthcare better. The
company offers innovative products and services in Orthopaedics, Medical
and Surgical, and Neurotechnology and Spine that help improve patient
and hospital outcomes. More information is available at stryker.com
and builttofuse.com.
Follow the Spine division on Twitter @stryker_spine.

References

  1. McGilvray, Kirk C., et al. Bony ingrowth potential of 3D printed
    porous titanium alloy: a direct comparison of interbody cage materials
    in an in vivo ovine lumbar fusion model, Spine J. 2018;
    Volume 18, Issue 7, 1250-1260.
  2. Karageorgiou V, Kaplan D. (2005) Porosity of 3D biomaterial scaffolds
    and osteogenesis. Biomaterials, 26, 5474-5491.

Content ID TRITA-PB-2_18140

Dr. Berven is a paid consultant of Stryker. His statements represent his
own opinions based on personal experience and are not necessarily those
of Stryker. Individual experiences may vary. A surgeon must always rely
on his or her own professional clinical judgment when deciding whether
to use a particular product when treating a particular patient. Stryker
does not dispense medical advice and recommends that surgeons be trained
in the use of any particular product before using it in surgery.

The information presented is intended to demonstrate the breadth of
Stryker product offerings. A surgeon must always refer to the package
insert, product label and/or instructions for use before using any
Stryker product. Products may not be available in all markets because
product availability is subject to the regulatory and/or medical
practices in individual markets. Please contact your Stryker
representative if you have questions about the availability of Stryker
products in your area.

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