SI Joint Fusion

SI Joint Fusion with the iFuse Implant System®

Indications

The iFuse Implant System® is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. It is also intended for sacroiliac fusion to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion or for acute, non-acute, and non-traumatic fractures involving the sacroiliac joint. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit www.si-bone.com/risks

The iFuse Implant System is designed to stabilize and fuse the SI joint. The iFuse procedure involves inserting typically three triangular-shaped titanium implants across the sacroiliac joint to maximize SI joint stability, reduce pain, and improve function. The procedure is done through a small one-inch incision and takes about an hour. SI joint treatment using the patented triangular design of the iFuse implant has been clinically evaluated more than any other SI joint fusion procedure.

The iFuse Implant System is designed to provide stabilization and fusion for certain SI joint disorders

More than 100, peer-reviewed publications demonstrate the safety, durable effectiveness, and biomechanical and economic benefits of the iFuse implant (www.si-bone.com/results). The iFuse implant is the only SI joint fusion device with multiple prospective clinical studies, including two randomized controlled trials6,7, demonstrating that treatment improved pain, patient function, and quality of life.6-11 As with any minimally invasive surgical procedures, there are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit www.si-bone.com/risks.

References

1. Bernard TN, et al. Recognizing specific characteristics of nonspecific low back pain. Clin Orthop Relat Res. 1987;217:266–80.
2. Schwarzer AC, et al. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
3. Maigne JY, et al. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.
4. Sembrano JN, et al. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
5. DePalma MJ, et al. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732-9.
6. Polly DW, et al., and the INSITE Study Group. Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction. Int J Spine Surg. 2016;10:Article 28. DOI: 10.14444/3028
7. Dengler J, et al. Randomized Trial of Sacroiliac Joint Fusion vs. Conservative Management for Chronic Low Back Pain Attributed to the Sacroiliac Joint. J Bone Joint Surg Am. 2019;101(5):400-11. DOI: 10.2106/JBJS.18.00022.
8. Duhon B, Bitan F, Lockstadt H, Kovalsky D, Cher D, Hillen T, on behalf of the SIFI Study Group. Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: 2-Year Follow-Up from a Prospective Multicenter Trial. Int J Spine Surg. 2016;10:Article 13. DOI: 10.14444/3013
9. Dengler J, et al. on behalf of the INSITE, iMIA and SIFI study groups. Predictors of Outcome in Conservative and Minimally Invasive Surgical Management of Pain Originating from the Sacroiliac Joint – a Pooled Analysis. Spine. 2017;42(21):1664-73. [Epub 2017 Mar 27]. DOI: 10.1097/BRS.0000000000002169
10. Whang PG, et al. Long-Term Prospective Clinical and Radiographic Outcomes After Minimally Invasive Lateral Transiliac Sacroiliac Joint Fusion Using Triangular Titanium Implants. Med Devices (Auckl). 2019;12:411-422. DOI: 10.2147/MDER.S219862
11. Patel V, et al. Prospective Trial of Sacroiliac Joint Fusion Using 3D-Printed Triangular Titanium Implants: 24-Month Follow-Up. Med Devices (Auckl). 2021;14:211-216. DOI: 10.2147/MDER.S314828

Hear from an iFuse Patient

Cara’s Story

“iFuse gave me my life back.”

Cara spent 10 years with debilitating SI joint pain that she had to plan daily activities around. Whether she wanted to go grocery shopping, do laundry, or spend time with loved ones‐her pain would often get in the way. Hear how SI joint fusion with the iFuse Implant System made a difference in her life.