Surgeons Share Spine Device Trends and Challenges

Cost, long-term results and clinical evidence remain at the top of surgeons’ lists when choosing which spinal device to use. In anticipation of spine companies and surgeons meeting at NASS this November, ORTHOKNOW® queried surgeons about the trends that excite them, the challenges they face and what they want device manufacturers to know.

This article originally appeared in the October issue of ORTHOKNOW.

The surgeon voices include:
Henry Aryan, M.D., spine surgeon at Sierra Pacific Orthopedics
R. Thomas Grotz, M.D., orthopaedic microsurgeon, spine device inventor (consulted with Sigurd Berven, M.D., professor in residence, Department of Orthopaedic Surgery, UC San Francisco)
Hooman M. Melamed, M.D., board-certified orthopedic spine surgeon for DISC Sports & Spine Center
Amir Vokshoor, M.D., neurological spine surgeon at DISC Sports & Spine Center

What current trends excite you in spine—what procedures and products particularly catch your eye, and why?

Aryan: None, really. I think spine technology and products available now are of high quality. The issue is trying to treat surgical problems in a cost-effective and long-term manner.

Grotz: New expanding cages that better align and repair spine maladies.

Melamed: Stem cell therapy has a lot of potential application in spine surgery, especially for patients with degenerative disc problems. There’s great potential to reverse or stop the natural, degenerative aging process, which could ultimately save a patient from requiring an operation. The role of non-fusion technology is also exciting. Dynamic stabilization could be developed more, and similarly save the patient from having to undergo fusion.

Vokshoor: I am most excited by the advancements in biologics and stem cells to regenerate disc, cartilage and eventually nerves. There are exciting technologies being developed in nanoplatforms, which create scaffolding of biological tissue growth with stem cells, as an added stimulation. These platforms could restore or regenerate injured tissues back to health. There is also great potential in the use of pluripotential stem cells in order to regenerate disc and cartilaginous tissue.

What should your device manufacturers know as they prepare to serve your needs?

Aryan: We need cost-effective and long-term treatment of spinal disorders. We need to change public and government opinion that spine surgery can be safe, effective and the best treatment for many conditions. There are several common misconceptions about spine surgery. Some have merit, and some are totally baseless. I think surgeons and industry need to do a better job of educating the public and government agencies (like CMS).

The common misconceptions are:

  1. Spine surgery (especially fusion) has a high failure rate and leads to more surgery. You are better off never having surgery.
  2. Surgeons perform too much unnecessary spine surgery (especially fusion surgery) and are motivated by greed. Industry supports this because they benefit from it and are also motivated by greed.
  3. Spine surgery is too expensive and is a drain on our healthcare system and society.
  4. Spine technology and equipment are too expensive and provide little added benefit to patients.

Grotz: The ideal concept that would “excite” me as a surgeon trying to correct spinal disease or injury conditions, is a cage that can be inserted from ANY angle circumferentially (limited by natural and post surgical anatomy), able to be used from the cervical to lumbar spine, as either a singular or doubled device (parallel or obliquely aligned if more than one are used)…an implant that can be safely inserted to expand as a Universally Expanding Cage (UEC). Externally, it can be shaped as a conduit that increases throughout its length as 40 percent in diameter, or as a rectangular or flat spacer inserted to precisely adjust spine angulations including scoliosis and kyphosis. Such a cage would minimize any injury to adjacent tissues on entry, and maximize the goal as of fusion (i.e. no motion in a pathologic area = no pain). Instrumentation would be as simple as percutaneous, arthroscopically facilitated or open, and it would allow immediate patient axial skeletal (spine) loading, enabling speedy return to work or sport. The inherent fixation of said UEC implant would immediately fix the spine mechanically, and in the long term by bone ingrowth via porosity producing fusion, or perhaps later with motion preservation.

The UEC implant will be amenable to 510(k) regulatory clearance, improving upon prior design and material assimilations.

Melamed: Device manufacturers should know that cost is a major consideration for spine surgeons. You want to do something to minimize the cost of the healthcare without compromising the quality. Ease of use and efficiency should also be major considerations.

Vokshoor: They should be well-versed in the cost of devices versus their efficacy, and their place along the spectrum of pathologies we hope to treat. There’s been an explosion of devices without due diligence of science. And, more importantly, to justify the cost, clinicians need to see scientific evidence.

What are your most significant challenges when using new spine devices?

Aryan: The desire by surgeons to use a new device is often viewed with skepticism and cynicism. Manufacturers need to help change public opinion about the benefits of spine surgery, and specifically the benefits of spinal instrumentation.

Grotz: Allowing treatment options from neck to low back, from any angle, with almost certainly positive surgical results, in a better, more economical fashion to promote spine fusion and realignment.

Melamed: When it comes to new spine devices, I am always wary about how effective they are, especially when they haven’t been in the market for very long. I would prefer to see long-term results before I justify spending money on a particular device. This goes hand-in-hand with costs, which are also a concern. At times, the cost is so high that it’s not justified when the device hasn’t proven itself yet, since a lot of devices tend to come into the market and are then removed.

Vokshoor: The biggest challenges we face are related to the engineering, form, function, ease of use and clinical efficacy of new spine devices.

 

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