Why the U.S. is so far behind in implementing appropriate Surgery for the Sacroiliac Joint, and why Europe is so far ahead

Currently the main surgery for sacroiliac joint fusion available in the U.S. is the minimally invasive lateral approach technique.  This approach utilizes a small 1-inch incision over the posterior lateral buttock through which a manufactured device(s) is introduced and pushed through the gluteal muscles, through the ilium (pelvic bone), across the sacroiliac joint, and into the body of the sacrum.  Depending on the device there may or may not be bone graft or synthetic fusion material placed within the device.  This also is the approach having the greatest potential for complications (see textbook referenced below).  These complications, all of which are relatively unique to this approach and all published, are hematoma of the gluteal muscles requiring surgical evacuation, fracture of the iliac wing of the pelvis, impingement of the S1 nerve root within the S1 foramen, fracture of the sacrum, and screw intrusion into the pelvis and bowel.  This is considered the standard approach for “fusing” the sacroiliac joint in the U.S. today.

 

In Europe there is much more variety in the way a sacroiliac joint is fused consisting of both the same lateral approach as described above, but with the addition of posterior approaches as well.  The posterior approaches avoid most of the complication pitfalls of the lateral approach.  This allows surgeons in Europe to have more flexibility in treating the painful dysfunctional sacroiliac joint patient depending on the specific cause of the pathological dysfunction and possible associated pathology in the lumbosacral spine.

 

Why are there not more options in the U.S.?  The simple answer is the Federal Drug Administration (FDA) regulations and the resulting cost of obtaining pre-market approval for devices not predating the creation of the FDA in the 1970s.  Surgeons in the U.S. have certainly created many different approaches, devices and ways to fuse the Sacroiliac Joint over a time spanning nearly a century since the first peer reviewed article was published on fusing this joint.  A textbook, which outlines many of these approaches, was recently published by Springer Publishing in 2015.

Surgery for the painful dysfunctional sacroiliac joint: a clinical guide 

http://www.springer.com

Editors: Dall, Bruce E., Eden, Sonia V., Rahl, Michael D. (Eds.) Comprehensive and practical resource for diagnosing and treating the dysfunctional sacroiliac joint.

Throughout this book several authors from all over the U.S. describe approaches, devices and fusion techniques that have worked for them in helping to relieve pain in hundreds of patients with chronically painful dysfunctional Sacroiliac joints.  Some of the posterior approach oriented approaches have been proven to have fewer complication rates than the current most commonly used lateral minimally invasive approach.  While this publication is helping to break down old barriers such as “does the Sacroiliac Joint really cause pain”, “this joint really doesn’t move that much to be important”, or “fusions of this joint really don’t work”, it’s greatest struggle for advancing many of the techniques described in this textbook and providing the surgical patient with more than one option is the FDA and it’s regulatory process.   Why is this the case?

 

To answer this question we need a brief amount of history to understand surgery on this joint.  Orthopedic surgeons have been “fusing” this joint for reasons associated with trauma since bone screws were invented.  When the pelvis was pulled apart at the sacroiliac joint in a violent fall or auto accident the sacrum and the pelvis were completely separated from each other.  The solution was to put two long bone screws across the sacroiliac joint to stabilize the pelvis.  Sometimes the joint went on to auto fusion and sometimes it did not.  Either way the success rate for not having debilitating pain long-term from that joint was about 50%.  As orthopedics became more sophisticated there came a point when a stable sacroiliac joint, one not having acute trauma, was able to be diagnosed as a pain generator in and of itself.  There is a chapter in the cited textbook that describes many of the pathological conditions that can contribute to such a joint, but in each instance the joint is stable and not acutely injured.  In the late 70s and early 80s the surgical treatment for such a joint was to put two screws across the joint, again with the approximate 50% success rate in relieving pain long-term.  A good surgical solution was not reliably available during that time.

 

It was during the late 1980s and into the present century that orthopedic surgeons began being more creative in addressing this painful condition in the stable sacroiliac joint by creating new approaches, many posterior or posterior lateral, to directly address the pathology within the joint itself.  As pointed out in the textbook many of these procedures were able to be done minimally invasively, with good success, minimal complications and few re-operations.  The newly designed procedures and the publications accompanying them were on track for positive change up until 2008.

 

It was in 2008 that one company created a device to “fuse” the sacroiliac joint using a minimally invasive lateral approach, as described in the first paragraph of this post.  What made this a game changer was that they applied for and received a 510 (k) designation from the FDA for their device, and its use for stabilizing the degenerative sacroiliac joint.  The reason they could obtain this designation was because the approach they were using, passing a device from lateral across the sacroiliac joint and into the sacrum, pre-existed the origin of the FDA in the 1970s.  This designation allowed the company to bypass the lengthy and costly (tens of millions of dollars) pre-market approval route.  The several surgeons and companies, who at that time, were poised to embark on the pre-market approval process for their posterior or posterior-lateral devices to enter the growing sacroiliac joint fusion market, quickly abandoned that option for this suddenly realized and much less costly 510 (k) option.  This has now become a “free-for-all” frenzy with multiple instrument companies consulting with multiple surgeons, to create “something” to get into this now well identified market.  The two things that most of these companies have in common are that they have walked through a very open door (the 510 (k) door) to get into the market.  Industry knew very little about the sacroiliac joint concerning how to appropriately diagnose a painful, dysfunctional sacroiliac joint, treat this joint with the most effective conservative measures in order to avoid a potential surgery, the various pathological conditions that can cause this joint to require treatment, and the other approaches and types of surgeries for the sacroiliac joint that might better serve a given patient.

 

In my opinion it is this “free-for-all” attitude that is currently causing surgical societies like the North American Spine Society (NASS) to shun the subject of surgery for the dysfunctional sacroiliac joint as they see companies and surgeons rushing to make a quick profit on a very unsuspecting public.  Unfortunately, some of the most influential people in NASS who might stand up against this movement consist of many who are financially caught up in this lateral sacroiliac joint fusion frenzy.

 

Europe, especially Germany, is out in front right now with the sacroiliac joint for several reasons.  They do not have to deal with the FDA on this issue, and they have created the first society that is totally dedicated to the surgical treatment of the sacroiliac joint (SIMEG). They are currently able to maintain a more open mind toward the full complement of conservative options available in an attempt to avoid a surgery, and, if surgery is necessary, they have more than one approach to treat a patient depending on that person’s unique pathological condition.  Their flexibility also is allowing them to embrace variables like lumbosacral spine pathology and sacroiliac joint pathology occurring in the same patient at the same time and needing to treat both for a satisfactory outcome.  In this particular patient using the lateral fusion approach for the Sacroiliac Joint makes this difficult.

 

As long as the financially easy and currently most lucrative way is the one taken when considering the sacroiliac joint and the 510 (k), the patient and their individual needs will always be considered last in our capitalistic system here in the U.S.

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