Here are five areas where spine research and development will focus prominently over the next few years.
1. Clinical outcomes research. There will be a huge focus on clinical effectiveness in the future, which means providing evidence-based outcomes. The government and insurance companies will be asking for comparative effectiveness research before agreeing to cover some procedures and patients will want to know their provider has good outcomes before undergoing treatment.
"Traditionally a lot of spine research has been on surgical techniques and on new or innovative surgical products, and I think that is still important, but a greater degree of impact will come out of research that looks at spine research as health outcomes research," says Alpesh A. Patel, MD FACS, spine surgeon and Associate Professor in the Department of Orthopaedic Surgery at Northwestern University School of Medicine in Chicago. "We need to really look at the patient-based outcomes for what we do. A lot of that is still in a black box, and not everyone understands how patients are doing after surgery."Surgeons can also take their research a step further to gather population-based outcomes, which gives them the ability to study a whole range of issues — such as genetics, epidemiology, readmissions and cost-effectiveness in addition to clinical quality.
"Research is more powerful when it's done at the population level," says Dr. Patel. "It makes what we do more relevant. We can look at a population of people with back pain and determine how effective our current treatments really are."
2. Patient database development. Health systems, national organizations and even physician practices have begun collecting patient data in large registries or databases for more accessible research. Electronic medical records have helped gather this data, but new efforts are connecting different individual registries so surgeons can mine large patient populations from around the country to really understand how effective treatments are.
"Some of the large databases are becoming available to use and registry tools are being developed," says Dr. Patel. "There are going to be a lot of surgeons involved and they will have an immediate impact on the care we provide patients. It will let us hone in and refine the things we do well. At a base level, it could serve as benchmarking for everyone, but also improve the quality of care development."
Technology now allows private practice surgeons to contribute their data to registries and study outcomes from large patient populations, so research isn't just for the academicians anymore.
"Surgeons at the large academic centers are the ones who are mostly engaged in research studies," says Samuel K. Cho, MD, spine surgeon and Assistant Professor of Orthopaedics in the Leni and Peter W. May Department of Orthopaedics at the Icahn School of Medicine at Mount Sinai in New York City. "However, increasingly more surgeons who aren't affiliated with academic institutions are doing research now. I would encourage that, and it all begins by maintaining patient profile data. This will not only help them to review their own outcomes, but also amass data from multiple surgeons into a study group to enhance the number of patients involved. Then surgeons can get funding for their study groups and through discussion come up with new and interesting ideas."
3. Stem cells and biologics. While the application of many biological treatments is still decades away, significant advancements are being made in the field. Synthetic biologics such as bone morphogenic protein have become more common in spinal fusion procedures and will continue to develop.
"Biologics is a huge topic in spine surgery right now, especially with controversy surrounding BMP," says Dr. Cho. "There are other biologics either on the market or in the process of being developed that will contribute to spine surgery, specifically the clinical trials for OP-1 and GDF-5. Biologic agents either for spinal fusion or spinal cord injury and neuro-protection are also in clinical trials. These areas will be interesting to watch as they develop."Other treatment, such as disc regeneration, will require much more research and development down the road.
"Regenerative and stem cell treatments are wonderful projects to work on, but we haven't seen a tremendous clinical impact yet," says Dr. Patel. "From an innovation standpoint, that's where we are going to see spine surgery heading. It will come to the point where we know how it works and is safe and cost-effective, but that's pretty far removed. However if surgeons are looking at research careers, biologics is a fantastic field to pursue."
4. Cost-effectiveness. As the Patient Protection and Affordable Care Act restructures the healthcare system, all stakeholders are going to pay close attention to the cost of care. In this emerging environment, cost-effectiveness research will play a key role in coverage and treatment decisions in the future.
"We as spine surgeons are obligated to demonstrate cost-effectiveness to the government and other agencies for our treatments," says Dr. Cho. "The entire field of medicine is focused on cost-effective research."
Expect to see more studies conducted that analyze the cost for an episode of care, comparing different treatment options. This will include not only the cost of the procedure, but also preoperative care, anesthesia, postoperative rehabilitation, hospital stays, loss of work days and associated complications.
"The ultimate goal of translation or clinical research is to help guide us to either perform a surgery better or at a lower cost with the same or better outcomes," says Dr. Cho. "If a certain procedure is effective but costs are prohibitive, we may be in a situation where we need to find an alternative or come up with ways to cut costs down. At the end of the day, that procedure may not be approved or reimbursed."
5. Artificial discs and motion preservation. Research and innovation in spine surgery over the past decade has focused on motion preservation techniques, and some companies have brought artificial discs to the marketplace. While current clinical studies are still in the works for long-term data with cervical discs, lumbar discs have been widely abandoned in the United States.
"Five year data suggests that cervical artificial discs are better or equivalent to anterior fusions, but adjacent segment disease and revision operations are similar between the two groups," says Dr. Cho. "In the long term, we will have to see whether disc replacement can truly cut down on re-operation for adjacent segment disease."
Outcomes for new disc replacement designs are currently being studied overseas, but it will likely take time before these developments move to the United States, if proven effectively. In the young field of motion preservation, there is plenty of room for future development.
"In 10 years, if data comes out suggesting the use of an artificial device can decrease adjacent segment disease rates, people will be more likely to use that device instead of the conventional ACDF," says Dr. Cho.
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