DePuy Synthes Introduces Innovative Zero Profile Cervical Spacer

When a patient has a degenerative disk in their neck and its pinching nerves, it can cause a lot of pain. When conservative treatment fails, surgery can be an excellent option.

And the surgery usually entails anterior entry (from the front), removal of the shrunken disc by the surgeon which is then replaced with a spacer and plate technology. But some plates may cause irritation to the surrounding anatomy.

DePuy Synthes’ new Zero-P Natural (short for Zero Profile) integrates metal with bone allograft (created and supplied by Musculoskeletal Transplant Foundation (MTF) and helps to streamline the surgery while also minimizing risk of irritation to soft tissue. Smart new product on several levels.

Here’s the main issue DePuy Synthes’ Zero-P addresses: the plate a surgeon uses to keep a spacer in place typically requires bone “leveling” work. That “leveling” allows the plate to lay flat and reduce the risk of patient irritation after surgery.

However, since DePuy Synthes’ new Zero-P Natural Plate integrates the plate and a bone spacer into one implant with a zero profile, there’s less work for the surgeon and potentially less risk of irritation to the patient’s anatomy.

“The integrated plate and spacer technology leaves nothing protruding beyond the vertebral bodies, so the risk of irritation after surgery may be reduced” said Matt Finn, group product director, North America Spine Marketing at DePuy Synthes. “A lot of surgeons are starting to prefer zero profile technologies.”

DePuy Synthes introduced Zero-P Natural at the recent North American Spine Society Annual Meeting. The new product was developed to help maintain stability and support bone growth in spinal fusion procedures in the neck. It is designed to be used with the CC Natural Spacer, an allograft or bone spacer that offers structural support and fusion potential.

Combining Bone Spacers With Zero-Profile Plates

Although zero-profile technology has been used for a while, the option of using it with a bone spacer hasn’t been available from DePuy Synthes until now, said Finn. Surgeons can choose from PEEK (plastic-like) spacers or bone (allograft) spacers. “If they chose PEEK spacers, they could also choose zero-profile technology or use a plate, but now we have a zero-profile option for using a bone spacer.”

The Zero-P Natural plate and CC Natural allograft spacer are assembled together outside of the operating field, which allows for single insertion into the disc space during anterior cervical discectomy fusion (ACDF) procedures. The Zero-P Natural Plate is anchored by four locking screws, which form a rigid bone wedge for stability, said Finn.

“Because the Zero P device is only going between the vertebrae into a disc space, you have a pretty small access channel and less work, ” explained Finn. “When you are putting a plate on the outside of the vertebral body you need much larger access and need to prepare the surface to lay the plate flat, because it can have different angles or bone growth.”

Zero-Profile Technology Should be Popular with Surgeons

The number of ACDF surgeries in the United States has been averaging about 250, 000 per year, with half of them performed using bone spacers, said Finn. “Since 50% of the market wants to use bone and never had the opportunity to use zero profile and now they do, I would expect this percentage to grow rapidly.”

Peyman Pakzaban, M.D., FAANS, Houston Microsurgery, can see the potential. “Compared to ACDF with a traditional plate and allograft, there is no need to expose the vertebral bodies beyond their endplates, resect anterior osteophytes, or remodel the anterior surface of the vertebral bodies. The insertion of a pre-fabricated allograft and the zero-profile plate is performed in one combined step.”

Internal engineers at DePuy Synthes developed the zero-profile technology and the allograft spacer is developed and provided by the Musculoskeletal Transplant Foundation. “Like everything we develop, of course, we collaborate with surgeons throughout the development process, both for the spacer design and the plate, which was integrated with the spacer, ” Finn said. “The technology builds on our original zero p plates, which have been on the market for a long time, so the technology we’re familiar with and the biomechanics.”

Finn said the Zero P Natural Plate with the CC Allograft Spacer is being used in a limited capacity until the product is fully launched on December 1, 2016.