Innovation in Spine MIS, Biologics & More: Can Anything Stem the Flow?

Anuja Vaidya -  

 

Here five spine surgeons discuss exciting innovations in spine surgery, roadblocks to spine surgery innovation as well as what they hope to see in terms of innovation in the next five to 10 years.

Question: What are some of the most exciting innovations in spine surgery at the moment?Cho

Samuel Cho, MD, The Mount Sinai Hospital (New York), The Expert Institute: There are several innovations. In the cervical spine, artificial disc replacement has been shown to have equivalent clinical efficacy compared to ACDF. The investigators are following patients long-term to see whether this motion preservation technology can decrease the incidence of adjacent segment disease.

 

Minimally invasive spine surgery now has some evidence to support that its use results in similar long-term clinical outcome compared to traditional open procedures with shorter hospital stay and quicker recovery. It has also been shown to be cost effective in a couple of papers. On the other hand, it exposes the surgical team to greater radiation.

 

Biologics are another exciting field. Many companies are coming up with stem cell-based products as bone graft substitutes. Its efficacy is yet to be proven.

 

Carlson useJeffery Carlson, MD, President, Managing Partner, Orthopaedic and Spine Center (Newport News, Va.): We are always looking for patient-specific improvements in our procedures. With advancing technology, some of the more complex procedures can now be done as outpatient. Patients don't really want to stay in a hospital overnight. The patients understand the need for the operating room but the potential risks in staying in the hospital environment frightens most patients. From wrong medications and wrong dosing to risks of hospital-acquired infections, patients don't want to add to the potential complications of their procedures.

 

Another development is the advances in anesthesia. Anesthetics are obviously necessary for the performance of surgery. With influence from patient demand, drug companies are making medications that can be used to decrease or prevent pain. These new medications will also have fewer side effects that have the potential to make patients uncomfortable and require a hospital stay. Patients are able to [procure] medications in real time to provide pain control and directly relate the need for treatment to activity levels.

 

mick use

Mick Perez-Cruet, MD, MSc, Chief, Spine Surgery, Department of Neurosurgery, William Beaumont Hospital (Royal Oak, Mich.): What interests me is minimally invasive spine (MIS) surgery and how innovations in MIS are being developed. I think, in general, we are developing certain technology for more focused care so that patients are recovering quicker and with better outcomes. We are treating a variety of pathologies of the skull base, cervical, thoracic and lumbar spine using MIS techniques and technologies.

 

I've been doing this for quite a while and we are definitely seeing long-term improvements that are lasting and satisfied patients who are receiving those treatments.

 

Thomas Schuler.High Res Head.Virginia Spine.favThomas Schuler, MD, FACS, CEO, Virginia Spine Institute (Reston): Developments in artificial disc technology, regenerative treatments for the disc and spinal structures as well as advancements in minimally invasive spine surgery are benefiting positive patients.

 

Hybrid cervical arthoplasty/fusion is a monumental improvement for our patients. The PRP injections and the stem-cell injections used intradiscally to repair the disc and ligament helps patients avoid surgery or postpone surgery. These non-operative options are helping improve patients' daily lives and function.  

 

Q: What are some new technologies you are using in your work?


Roger Hartl MD 63

Roger Hartl, MD, Chief, Spinal Surgery, NYP/Weill Cornell Medical Center (New York): I use a lot of 3D navigation for spinal surgery cases. The technology has been available in the last 10 years, but it has evolved, and it has now become more user-friendly.

 

Dr. Schuler: We're using posterior Mazor robot-guided surgery, lateral interbody fusions with plate fixation and anterior spine reconstruction to advance minimally invasive spine procedures. These approaches are improving patient outcomes.

 

Stem cell injections for disc regeneration and complex cervical hybrid arthoplasty-fusion operations are providing our most exciting advances for patients.

 

Dr. Cho: I utilize artificial disc replacements and minimally invasive techniques when appropriate. I am waiting for more evidence on stem cell technology.

 

Dr. Perez-Cruet: We are using MIS technologies that reduce cost while improving fusion rates, facilitate MIS procedures and reduce radiation exposure to surgeons. Many of these have been developed working with Thompson MIS.

 

Q: What are some of the roadblocks to innovation in spine surgery?

 

Dr. Hartl: The lack of spine surgeons who are interested in conducting spinal research. We have a great lack of understanding about what is causing degenerative spine and why it causes pain. The research that is necessary to understand these pathologies better, but not a lot of spine surgeons are interested in doing it. Also, there is a lack of infrastructure in which to conduct this research.


Another problem is the tendency among spine surgeons to focus on instrumentation and fusion surgery. They are so focused on implants and that makes it difficult to open them up to other treatment options such as minimally invasive spine surgeries or biologics that can help avoid fusions.

 

Dr. Perez-Cruet: One of the biggest roadblocks is finding good partners to work with to develop these technologies. Also, it takes money and resources. Currently, there is a concern amongst the companies about making large investments in healthcare when they are not sure if they are going to be reimbursed for developing these technologies. Whether the current changes in healthcare will foster reimbursement for these technologies remains to be seen.

 

Dr. Cho: I think it would be the cost. In order to run an investigational device exemption trial, companies need to spend millions of dollars. I don't know how this problem can be overcome. Medical research is expensive and we don't want to cut corners either.

 

Dr. Schuler: The biggest roadblock is insurance companies, governmental payers and third-party payers denying physicians and patients the ability to undergo contemporary treatments and denying physicians the ability to perform these modern surgical advances. They are denying patients access to life-improving spinal surgeries, and Obamacare has made this much worse.

 

We are seeing an enormous rise in denials for patients to certain types of care and an increase length of time for approvals for all procedures. To overcome this negative process, physicians need to continue producing data showing which techniques work most effectively. This needs to be financed through patient-centered funding programs and nonprofits, not corporate funding. The insurers and the third-party payers are discrediting research funded by corporations and are claiming that there is a conflict of interest. Payers are choosing the studies that support their reimbursement policies and are denying any studies that counter their financially motivated coverage decisions. This is unethical, and it is wrong.

 

Q: How can surgeons overcome some of the regulatory burdens on innovation?

 

Dr. Perez-Cruet: We need to be able to foster innovation from a regulatory and governmental standpoint. We need to think about how we can make bringing products to the marketplace easier and in ways that are not cost-prohibitive. There are ways in which it could be more streamlined.

 

Also, there needs to be legislation that protects innovation. There should not be a huge liability burden for bringing new technologies to the marketplace.

 

Q: Will the current healthcare environment bring spine surgery innovation to a standstill?

 

Dr. Carlson: Advances in spinal care will continue although it maybe slowed by changes in the healthcare system. As patients demand improvements in their care, it will be the healthcare system that may not be able to respond quickly enough to the demand. There will always be a demand for the innovative care that provides the best outcome, but the system is slow and bulky and will lag behind the desires of the patients. I believe over the next few years, healthcare delivery will change drastically.  

 

Unfortunately, I see the current system as a hindrance to advancement. This means that patients will seek care outside of the system anytime they have a chance. This will slow the ability of the best and brightest among us to make the improvements that will be demanded in the future. I see most surgeries trending toward outpatient environments and hospitals becoming less relevant to the healthcare systems as a whole.

 

Dr. Perez-Cruet: I don't think it will bring innovation to a standstill. Companies will have to foster innovations that provide cost-effective care. There will always be value in products that improve healthcare for patients.

 

Q: What do you hope to see in terms of spine surgery innovation in the next five to 10 years?

 

Dr. Perez-Cruet: I think we can do a better job understanding the pathophysiology of some of the disorders that we treat, so that we can enable more focused treatments, which can provide patients with really improved quality of life. A more focused approach addressing the underlying cause of the patient's symptoms is what we need. Additionally, I feel that biologic restoration of the spinal column — that is, intervertebral disc via stem cells — may become a reality.

 

Dr. Schuler: Regenerative techniques, which will obviate the need for many surgeries. The more we can heal through regenerative treatments, the more the patient can avoid or procrastinate the need for surgery.  

 

Dr. Cho: I would like to see long-term follow-up studies on cervical artificial discs. Hopefully, they will answer whether this technology can decrease the incidence of adjacent segment disease and also stay functional over time.

 

If there is a way to decrease radiation exposure during minimally invasive surgery, I think that would be a huge step forward. I would like to see more data on biologics such as stem cell technology before they are applied in humans.

More Articles on Spine:

Anterior Spine Surgery for Disc Herniation at C7-T1: Outcomes Analysis
Orthopedic, Neurosurgeon Roles: Medical Teaching, Administrative & Research
Growing Patient Volume in 2014 & Beyond: 4 Spine Surgeon Initiatives

 

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