The North American Spine Society (NASS) has issued a formal coverage recommendation for SI-Bone’s minimally invasive sacroiliac joint fuse system—iFuse. The evidence-based coverage policy is based primarily on the 19 published iFuse clinical studies, from which the committee concluded that the sacroiliac joint is an established source of chronic low back and buttock pain and that the joint fusion procedure has proven to be relatively safe.
The coverage criteria outlined in the document intend to ensure that nonsurgical options have been thoroughly evaluated for at least six months and also to confirm that the sacroiliac joint is the primary pain source while ruling out other potential sources of pain within the lumbar spine–hip–sacroiliac joint complex through a combination of imaging studies, physical examination tests and an intra-articular sacroiliac joint injection. The committee notes that although there is no single clinical, imaging or provocative test that definitely confirms the sacroiliac joint as a primary pain source, a critical step in confirming the joint as the source of pain involves a diagnostic intra-articular injection with local anaesthetic.
The committee summarised that available evidence shows pain score outcomes appear to be consistent and improve with both open and minimally invasive sacroiliac joint fusion procedures, but minimally invasive procedures seem to be associated with less blood loss and fewer complications compared to open procedures.
Clinical publications have identified the sacroiliac joint as a pain generator in 15–30% of low back pain patients. In addition, the prevalence of sacroiliac joint pain in post-lumbar fusion, so-called failed back surgery patients, has been shown to be up to 43%. Of these patients, some may have degenerative sacroiliitis or sacroiliac joint disruptions. Initial treatment options for patients with sacroiliac joint disorders typically involve non-surgical management and, when non-surgical management of the joint fails, other minimally invasive surgical options may be considered.