iFuse offers long-term treatment option for SI joint pain patients

Written by In Collaboration With SI-Bone | September 26, 2019 | Print  |

Lower back pain (LBP) is one of the most prevalent musculoskeletal conditions and a significant public health burden.Clinical publications have identified the SI joint as a pain generator in 15-30% of chronic LBP patients.2–6 The prevalence of SI joint pain in symptomatic post-lumbar fusion patients is even higher, ranging from 32-43%.7–10 

Becker’s recently spoke with two surgeons and an interventional pain management physician about their experience with the iFuse Implant System®, the collaborative relationships among providers that they’ve developed to both diagnose and treat these patients, and the impact this treatment option could have on the healthcare community. Adam Bruggeman, MD, a spine surgeon at Texas Spine Care Center in San Antonio; Ahmed Khan, a spine surgeon at Central Connecticut Neurosurgery & Spine in New Britain; and Marc Orlando, MD, a pain management physician at Mayfield Brain & Spine in Cincinnati, discuss their experiences with minimally invasive sacroiliac joint fusion.

Question: I’d like to hear how you were initially introduced to MIS SI joint fusion, and why you chose to incorporate iFuse specifically into your practice?

Dr. Adam Bruggeman: I was introduced to MIS SI Joint fusion in discussions at meetings across the country. The initial discussions really came from trauma surgeons frustrated at the use of the same code that they utilized for trauma. At the same time, surgeons that I knew were beginning to utilize the technology. I began to incorporate SI joint fusions into my practice based on the data. I think that at the end of the day, surgeons would like a predictable outcome and to be able to tell patients that what they will be doing for the patients will provide
the relief the patient is seeking. Without personal experience from training on the outcomes of these types of procedures, I looked to the data that was produced by the various studies done by spine surgeons across the country and in Europe. I felt the data was compelling and began utilizing the procedure for appropriately selected patients in my practice.

Dr. Marc Orlando: I was initially introduced to the procedure by a former neurostimulator representative who had recently started with the company. I immediately recognized that SI Joint Dysfunction is a condition I commonly see in my practice. It’s a very frustrating condition in the sense that I believe this is a true diagnosis, but we’ve been limited with long-term treatment options. It was nice to hear that there was a new MIS procedure to address this condition, one that also was supported by good scientific evidence and published data. I think the company now has over 70 peer reviewed publications. Prior to iFuse, there weren’t a lot of surgeons treating SI Joint Dysfunction. I brought this to a couple of the neurosurgeons in my practice at Mayfield Brain & Spine. I initially told them that I believe this condition exists, that we can develop a protocol and find a way to treat these patients. We got educated on the diagnosis, protocol and surgical procedure and incorporated it into our practice. We now have six surgeons in our practice who offer the procedure. It’s really meant a lot to our practice.

Q: Talk me through the protocol all of you have developed and implemented in your practice from diagnosis to surgical intervention for your patients.

Dr. Ahmed Khan: I think you have to begin with the history of the back pain, when and where it started. I’ve seen a lot of patients with prior lumbar fusion who then developed SI Joint pain afterward. Then I perform the physical examination including provocative testing, and once I feel certain that this
is an SI Joint issue, I send them for diagnostic injections. If patients have significant improvement post injection, I will then recommend SI joint fusion.

MO: We realized that we need to streamline how and what we needed to treat these patients, so we created an MIS SI Joint fusion medical necessity folder, which is in our computer system. It’s worked wonders for our practice. We even have patients who come in requesting the “SI Joint Protocol”. We can
now use the template in our computer system to help determine what has been done to diagnose and treat their SI Joint Dysfunction. We have check boxes to confirm that at least three positive provocative maneuvers yielded positive results (along with date of the exam), what diagnostic testing has been done to date, etc. Once they’ve met those criteria, we will typically put them through our diagnostic injection series with maneuvers performed pre- and post-injection, where we are looking for at least a 75% reduction in pain post-injection.

Once this protocol has been performed, they are considered a surgical candidate. We then refer them over to the surgeon, and at that point the Medical Necessity sheet is completed with the relevant information. The surgeon can then have a really good discussion about the pros and cons of the surgical procedure and can address each patient’s questions.

Q: Explain to me the relationship within your practice, between interventional pain management and the surgeon, and the process you have collaboratively developed.

AB: I work with many pain management doctors throughout the city. In some cases, the only patients we share are those that have SI joint dysfunction. With other doctors, we collaborate on many different kinds of patients. I have worked to educate providers in the city about the data that has been produced to date, and I think that in turn has helped providers to identify patients who may benefit from the iFuse product.

MO: As a pain provider, this was an opportunity to meet with surgeons to talk to them about how to identify this problem. Surgeons typically rely on MRI’s to diagnose lumbar problems. SI Joint Dysfunction is much more of a hands-on diagnosis. I have had the opportunity to provide a lot of education and I teach that you have to physically examine the patient in order to diagnose the condition. In addition, we have educated our surgery center and our hospital staff as we now go see the patients a half hour after the diagnostic injection to examine them and perform the provocative maneuvers.

AK: It is important to have a good relationship with a pain management physician as they are seeing many patients with SI Joint Dysfunction. For the subset of these patients that require repeated steroid injections or RFA procedures, and are still having SI Joint pain, MIS SI Joint fusion with iFuse may be a good longterm treatment.

Q: How have you worked to build patient and community awareness of SI Joint Dysfunction, diagnosis and treatment?

AK: In my opinion the awareness of SI Joint Dysfunction is lacking, even amongst referring and primary care physicians. Many of them think that lower back pain always comes from the lumbar spine. I have worked to educate PCPs, advanced practice providers and pain management physicians about SI Joint Dysfunction. We have done patient lectures on this topic where many patients realize that their symptoms could be secondary to SI Joint Dysfunction, but no physician has ever considered that diagnosis.

MO: We have created patient education content specific to the SI joint. This includes the typical history, common signs and symptoms, and the non-surgical and surgical treatment options. I can’t tell you how many patients go online and view and print the information on an almost daily basis. I think that when patients see this level of information, it gives them confidence that we recognize this as a real condition. This is important because many of these patients have already seen other providers who didn’t believe this was a real condition. We’ve also done outreach programs where we’ve invited patients, providers, or the public to come to our practice to learn more about the SI joint. Dr. William Tobler, my neurosurgeon colleague at Mayfield Brain & Spine, and I even have two educational YouTube videos, which have been watched thousands of times. We have patients who come to us from all over seeking this treatment because of the education and protocol we’ve put in place.

Q: In your opinion, how does a procedure like iFuse align with overall healthcare initiatives today?

AB: At the end of the day, we need to show value for what we do. In today’s world, a lumbar fusion done when the pathology was truly SI Joint Dysfunction can lead to significant short- and longterm costs. The patients, insurance companies, government, and
providers all benefit when an accurate diagnosis is achieved along with a clinically proven solution. Research has also been done to show the cost effectiveness of the procedure.

AK: I think that if we are looking for good outcomes, then we need to be able to have the correct diagnosis and identify the proper pain generator for patients with lower back pain. In my opinion, in a good portion of these cases, the SI joint could be responsible, and we should identify and treat this condition. Having the right diagnosis and then performing the appropriate procedure is what is going to give you the best outcomes for the patient. 

The iFuse Implant System, commercially available since 2009, is the only SI joint fusion product in the U.S. with proven clinical safety, effectiveness, durability, biomechanics and economic value supported by more than 70 peer-reviewed publications. As of June 2019, over 40,000 iFuse Procedures have been performed worldwide by over 1,900 surgeons, with the majority being performed in the United States (32,000+ procedures; 1,300+ surgeons). 

Over 100 health plans, including all Medicare Administrative Contractors, Tricare, UnitedHealthcare, 30-plus BCBS plans, and other large commercial health plans cover SI joint fusion, many exclusively with the triangular iFuse Implant System. The procedure is performed in all three sites of service, depending on the condition and health of the patient.

*Marc Orlando, MD is a pain consultant of SI-BONE, Inc.

REFERENCES

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