Advancing Quality of Life for Patients with Chronic Low Back Pain: Safety and Efficacy of Lateral Transiliac Sacroiliac Joint Fusion

In a recent meta-analysis of the safety and efficacy of minimally invasive sacroiliac joint fusion published in the International Journal of Spine Surgery, the lateral transiliac (LTI) approach utilized by the iFuse Implant System® demonstrated the most clinically meaningful and durable results.¹

The Level 1 systematic review showed:

• 4.8/10 mean reduction in pain on VAS

• 25.8/100 mean reduction in disability on ODI

• Low rate of complications (<1%)

“This publication is a milestone in the history of sacroiliac joint fusion (SIJF),” said Dr. Peter Whang, Professor of Orthopedics and Rehabilitation, Yale School of Medicine, and author of the meta-analysis. “For physicians who are reluctant to identify and treat sacroiliac joint dysfunction (SIJD), this systematic review provides strong support for the near universal payor coverage of LTI SIJF as the standard of care for patients with SIJD.”

An Overlooked Source of Low Back Pain

The sacroiliac (SI) joint, the body’s largest joint, transfers load from the spine to the lower extremities during normal activity. It is also a contributing factor in 15-30%² of patients with chronic low back pain and up to 43%³ in patients with new onset or continued back pain after lumbar fusion.  

Causes of SIJD include:

• Joint degeneration, including osteoarthritis and adjacent segment disorder
• Trauma  
• Changes in joint function related to pregnancy

Diagnosis involves a combination of medical history, physical examination, and diagnostic SI joint block. There is no radiographic test for SI joint pain. Chronic SIJD unresponsive to non-surgical treatment imposes a burden of disease as severe as other surgical conditions such as hip osteoarthritis, lumbar stenosis, and lumbar spondylosis.⁴ Failure to recognize the condition is common and some patients may undergo misdirected surgical procedures.⁵

Figure 1. Reported health state utility values for major diseases.

A Patient First Innovation

The iFuse Implant System is a minimally invasive triangle-shaped medical device designed to stabilize and fuse the sacroiliac joint.  It was tested in two randomized trials (INSITE, iMIA)^6,7, two prospective single-arm trials (SIFI, SALLY)^8,9, and a long-term 5-year prospective trial (LOIS)¹⁰. A summary of these trials showed:

• Sustained improvement in pain and function out to five years

• Minimal response in patients undergoing non-surgical treatment

To date, over 120 studies have been published regarding SIJF with iFuse implants. An average patient satisfaction of 91% has been shown.¹¹

Figure 2. Reported patient satisfaction across studies with iFuse implants.

Recent Data Demonstrate Success

Multiple approaches for SIJF are available, including LTI, posterolateral transiliac (PLTI), a variant on LTI, and posterior intra-articular (PI). LTI and PLTI procedures are typically reported via CPT 27279. PI procedures are reported via CPT 0775T, with a Category I CPT code (CPT 27278) effective January 1, 2024.

Figure 3. Diagram of various trajectories for SIJF.

The systematic review assessed the literature supporting the safety and effectiveness of LTI, PLTI, and PI approaches for minimally invasive SIJF.1 Results showed:

• LTI has the largest body of evidence (75% of patients)
  
  
• LTI has the largest mean improvements in pain scores (0-10 scale)
  • LTI: 4.8 points
  • PLTI: 4.2 points
  • PI: 3.8 points (P = 0.1533)
    
    
• LTI has the largest mean improvements in ODI scores (0-100 scale)
  • LTI: 25.9 points 
  • PLTI: 6.8 points
  • PI: 16.3 points (P = 0.0095)
    
    

• Adverse event reporting quality varied across studies. Rates of events summarized below:
  • Acute symptomatic implant malposition was <1% in all procedure variants
  • Wound infection was rare (0.15% or lower)
  • Bleeding requiring surgical intervention was rare (0.04%)
  • There were no reports of device breakage or migration 
    
    

• Radiographic imaging evaluation of implant placement/migration and fusion was only available for LTI. Notable findings included:
  • Low rate of implant malposition
  • High rate of radiographic fusion stable to 5 years

“The emphasis on these studies has always been on tracking what matters most to patients – pain improvement, disability reduction, and long-term durability of results. In my practice, patients who undergo LTI SIJF with the iFuse Implant System report long-lasting improvement in pain, disability related to pain, and quality of life,” said Dr. Whang, who has performed over 200 SIJF cases to date.

SI-BONE is a global leader in technology for surgical treatment of musculoskeletal disorders of the sacropelvic anatomy. In 2009, SI-BONE pioneered the iFuse Implant System® to treat SIJD. To date, over 90,000 iFuse procedures have been performed globally.

Learn more about SI-BONE treatments, outcomes, and support by visiting https://si-bone.com/providers

1. Whang PG, et al. Int J Spine Surg. 2023 Oct 5:8543. DOI: 10.14444/8543.
2. Bernard TN Jr, Kirkaldy-Willis WH. Clin Orthop Relat Res 1987; Schwarzer AC. Spine 1995; Maigne JY, et al. Spine 1996; Irwin RW, et al. Am J Phys Med Rehabil 2007; Sembrano JN, Polly DW Jr. Spine 2009.
3. DePalma MJ, et al. Pain Med 2011.
4. Cher D, et al. Med Devices (Auckl). 2014;7:73-81. DOI: 10.2147/MDER.S59437.
5. Vanaclocha-Vanaclocha V, et al. Br J Neurosurg. 2019;33(1):12-6. [Epub 2018 Nov 19]. DOI: 10.1080/02688697.2018.1527012.
6. Polly DW, et al. Int J Spine Surg. 2016;10:Article 28. DOI: 10.14444/3028.
7. Dengler J, et al. J Bone Joint Surg Am. 2019;101(5):400-11. DOI: 10.2106/JBJS.18.00022.
8. Duhon B, et al. Int J Spine Surg. 2016;10:Article 13. DOI: 10.14444/3013.
9. Patel V, et al. Med Devices (Auckl). 2021;14:211-216. DOI: 10.2147/MDER.S314828.
10. Whang PG, et al. Med Devices (Auckl). 2019;12:411-422. DOI: 10.2147/MDER.S219862.
11. Rudolf L. Open Orthop J 2012; Sachs D, et al. Adv Orthop 2013; Cummings J, et al. Ann Surg Innov Res 2013; Gaetani P, et al. J Neurosurg Sci 2013; Sachs D, et al. Med Devices (Auckl) 2014; Rudolf L, et al. Open Orthop J 2014; Vanaclocha V, et al. J Spine 2014; Duhon B, et al. Int J Spine Surg 2016; Polly DW, et al. Int J Spine Surg 2016; Dengler J, et al. J Bone Joint Surg Am 2019; Patel V, et al. Med Devices (Auckl) 2019; Whang PG, et al. Med Devices (Auckl) 2019.