Established as the market leader in the minimally invasive approach to sacroiliac (SI) joint fusion, SI-BONE, is now transitioning into a comprehensive sacropelvic solutions company.
Over the past 10 years, nearly 50,000 cases have been performed with SI-BONE's iFuse Implant System®, which has been evaluated in over 80 peer-reviewed publications (www.si-bone.com/results).iFuse has become the standard of care for SI joint fusion.
SI-BONE has initiated a randomized controlled trial at 22 academic institutions who have adopted the iFuse technology for SI joint treatment for deformity applications, including long constructs with spinopelvic fixations and degenerative SI joint dysfunction, and has expanded into the trauma market with its latest indication for acute, non-acute and non-traumatic fractures involving the SI joint.
Becker's recently spoke with three surgeons about why they use iFuse, patient indications, and how it differentiates from other technologies on the market.
Juan Uribe, MDi, a neurosurgeon with Barrow Neurological Institute in Phoenix; Ivan LaMotta, MD, a spine surgeon with Midlands Orthopaedics & Neurosurgery in Columbia, SC; and Christopher Boone, MD, an orthopedic surgeon with Proliance Orthopaedics & Sports Medicine in Bellevue, WA., share their insight on MIS SI joint fusion.
Question: How did you start working with SI-BONE’s technology and why?
Dr. Juan Uribe: I began performing SI fusions with SI-BONE's technology eight years ago. With the company's SI joint research, experience and publications, I think it's the market leader in this space. Recently, SI-BONE launched a new alternative, iFuse Bedrock TM, that addresses more issues in the sacropelvic area — specifically long construct and scoliosis cases where instrumentation typically ends at the iliac area and the SI joint gets exposed to significant stress. iFuse Bedrock TM helps achieve fusion to supplement stabilization and immobilization of the SI joint. In fact, we conducted biomechanical research here at BNI and found that iFuse Bedrock TM reduced S2AI screw bending by ~50% and reduced SI Joint range of motion by 30%1
Dr. Ivan La Motta: Prior to SI-BONE, there were no other good surgical alternatives for the treatment of SI joint pathology. During my training, SI joint pain was primarily managed by pain management physicians with endless steroid injections. In the past decade, there has been a growing body of evidence favouring surgical management of chronic SI joint pain. The iFuse clinical trials were the first to demonstrate that adequately selected patients with SI joint dysfunction can benefit from MIS SI joint fusion.
Q: Which indication(s) do you use the iFuse Implant System for and why?
Dr. Christopher Boone: I use the iFuse implant for SI joint dysfunction. Essentially, anybody who gets more than 60 percent or 70 percent pain relief with two injections, anyone who has positive physical exam findings or meets indications for SI joint dysfunction or SI joint degeneration. I’ve also been using it for trauma cases lately, where patients can have a dislocation of the pelvis or the SI joint.
JU: The main indication is for SI joint dysfunction and degeneration. Lately I’ve been using the iFuse Bedrock™ application which has become an excellent alternative for patients with spinal deformities, where there is a tendency to have SI joint dysfunction after fusion. The new Bedrock application provides additional stability and fusion to the SI Joint in conjunction with pelvic fixation.
Q: What differentiates the iFuse Implant System and approach from other technologies on the market?
JU: One is the experience and the research and background that comes with SI-BONE as a company. They are definitely the leaders in SI joint and everything at SI-BONE is driven by research and results. The other thing is their latest generation of implants which are unique to their triangular shape and also 3D printed. These are my go-to implants for SI fusion cases.
CB: It's a completely unique implant that nobody else has. It's 3D-printed lattice design facilitates bone ingrowth/through growth. I’ve had challenges with screw-based technologies in the past. In my opinion, the iFuse Implant is a stronger and more robust implant from what I’ve used in the past.
IM: The salient factor that differentiates the iFuse implant is the amount of solid clinical evidence that supports its use in the surgical treatment of SI joint pathology. Currently, there is only modest clinical evidence to support the SI joint products of the other companies. The procedure is reproducible and accurate with a relatively short and shallow learning curve.
Q: Have you noticed a shift in MIS SI joint fusion (SIJF) procedures moving outpatient? If so, how has that evolved in your practice and facility?
IM: In my opinion, MIS SIJF with iFuse is an outpatient procedure at its core. Over the last two years, we've rarely admitted patients postoperatively for pain control or other issues. In our practice, we've been able to migrate more and more MIS SIJF to our ASC due to increasing positive coverage by the insurers. As a result, only patients that are deemed to be high risk are taken to the hospital setting.
CB: I've been doing the vast majority of these procedures in the outpatient setting for a couple of years and it has been very successful. The exception being patients with comorbidities or who are sick or elderly. This is not a surgery that takes three hours and patients stay in the hospital for two days. I tell patients that, typically, by two weeks you're glad you had it done and by six weeks you should be better than you were before surgery. Hopefully, by three to six months you forget you ever had surgery.
Q: More and more payers are now covering MIS SIJF, with now over 300 Million covered lives across the US. Can you summarize the impact has this had on your practice and patients?
CB: When I first started doing this we would have appeals that would go on for up to a year and the denial rate was well over 50 percent. And I have to say I don't remember the last true denial we had. We have indications and multiple studies to prove that this works and I think as far as patients are concerned we've finally reached the tipping point where this is going to become the standard of care.
IM: The fact that more payers are covering this procedure goes in tandem with the growing body of evidence supporting clinical outcomes of MIS SIJF. As prevalent as SI joint dysfunction is nationwide, it's imperative to have adequate coverage for all patients so that spine specialists can offer SI joint fusion as an integral part of the standard of care. In our practice, we've been able to help a growing number of patients that were previously stuck in eternal cycles of pain management procedures. Positive insurance coverage has translated into being able to definitively treat SI joint dysfunction in the majority of these patients.
1 “Barrow Neurological Institute 2019. SI-BONE Technical Study 300720-TS.”
i Dr Uribe is a paid consultant of SI-BONE