iFuse Implant System (SI-Bone Inc.) for Sacroiliac Joint Fusion for Treatment of Sacroiliac Joint Dysfunction

Health Problem: Low back pain is the most common cause of chronic pain, with an estimated worldwide prevalence in adults ranging from 4% to 25%. The sacroiliac joint (SIJ) has been implicated as the primary source of pain in up to 10% to 30% of patients with chronic low back pain, although no widely accepted reference standard exists for the diagnosis of pain originating from the SIJ.

Technology Description: The iFuse implant system consists of sterile, rigid, titanium rods that have a triangular cross-section to minimize rotation and maximize surface area of the SIJ. These implants are coated with a porous titanium plasma spray to facilitate biologic fixation to bone. A series of 2 to 4 implants are placed in a lateral-to-medial direction across the SIJ via a minimally invasive surgical procedure.

Controversy: Patients with low back pain due to SIJ dysfunction typically follow a course of treatment, including nonsurgical management (NSM). For those in whom NSM does not achieve success in alleviating pain, surgical relief becomes an option. SIJ fusion via open surgery may provide pain relief but has many disadvantages, including: a large incision; bone harvesting and grafting; long operative times; significant blood loss; extended hospital stay; high complication rates; and prolonged postoperative rehabilitation. The lack of a widely accepted reference standard by which SIJ dysfunction can be diagnosed further complicates issues.

Key Questions:

  • Is minimally invasive SIJ fusion with the iFuse implant system effective in treating low back pain related to SIJ dysfunction?
  • How does minimally invasive SIJ fusion with the iFuse implant system compare with other minimally invasive treatments for SIJ dysfunction?
  • Is minimally invasive SIJ fusion with the iFuse implant system safe?
  • Have definitive patient selection criteria been identified for minimally invasive SIJ fusion with the iFuse implant system for treatment of low back pain related to SIJ dysfunction?

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