iFuse: A MIS Treatment Option for Fusion of the SI Joint


Once the SI joint is confirmed as the cause of a patient's symptoms, treatment can begin. Some patients respond to physical therapy, use of oral medications, as well as injection therapy. Intermittent use of a pelvic belt may provide symptomatic relief as well. These treatments are performed repetitively, and frequently symptom improvement using these therapies is temporary. At this point, you and your patient may consider other options, including minimally invasive surgery.

SI Joint Fusion With The iFuse Implant System®

Lower Back Pain SI Joint Pelvis Image

The iFuse is a minimally invasive surgical option, designed to be less invasive than traditional open surgical SI joint fusion. 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. The procedure typically involves three small titanium implants surgically inserted across the SI joint. It is designed to fuse and stabilize the SI joint. The procedure is done through a small incision and takes about an hour.

With the iFuse Implant System, there is no need for: BMP in conjunction with autologous bone graft, additional pedicle screws and rods, hollow modular anchorage screws, cannulated compression screws, threaded cages within the joint, or facture fixation screws.

iFuse Clinical Summary

iFuse has been marketed in the U.S. since November 26, 2008.

Over 20,000 procedures have been performed with the iFuse Implant System.

More than thirty published articles listed below have reported on the safety and effectiveness of the iFuse Implant System.1 iFuse is the only SI joint fusion device with published results from a randomized controlled trial and the only one with clinical studies demonstrating that treatment improved pain, patient function, and quality of life.2 Outcome measures include the visual analog scale (VAS), Oswestry Disability Index (ODI), quality of life (SF-36), and patient satisfaction with the surgery. An independent review of the company complaints database with information on over 5,000 procedures documents a low complaint rate and a low revision rate.3 The following summary tables include patients who underwent the iFuse procedure for SI joint disruptions or degenerative sacroiliitis.

iFuse Potential Benefits:

iFuse Implant Image
  • Less invasive than traditional open SI joint fusion surgery with no extensive soft tissue stripping
    • Plus: minimal incision size (approximately 2-3 cm long) and minimal tendon irritation
  • Minimally invasive surgical approach
  • Designed for maximum joint stability
    • Triangular implant profile minimizes rotation and an interference fit minimizes micromotion
    • An interference fit between the implant and the adjacent osseous walls
    • Porous titanium plasma spray (TPS) coating allows for biological fixation
    • Designed specifically to stabilize and fuse the heavily loaded SI joint
    • Rigid titanium construction and implant geometry provide immediate stabilization

    Simplified surgical procedure with iFuse

    • Pin, drill, broach, insert implants, and close
    • Procedure takes about an hour
    • Potential for less blood loss and reduced soft tissue damage

    iFuse Surgical Technique Overview:

    iFuse Surgical Technique Overview

    More iFuse resources:

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. Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life. 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, click here.

References:

1 Polly, D.W. et al., Neurosurgery. 2015.— Dr. Polly is an investigator on a clinical research study sponsored by SI-BONE. He has no financial interest in SI-BONE. Research was funded by SI-BONE, Inc. A list of additional published studies is available at www.si-bone.com/results.

2 Duhon, B* et al., 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. * Paid consultant of and conducts clinical research for SI-BONE Inc.

3 Miller, Larry, W. Carlton Reckling*, and Jon E Block. 2013. “Analysis of Postmarket Complaints Database for the iFuse SI Joint Fusion System: A Minimally Invasive Treatment for Degenerative Sacroiliitis and Sacroiliac Joint Disruption.” Medical Devices: Evidence and Research 6 (May): 77–84.

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