An earlier publication of 12-month results from SALLY (Patel 20205) reported radiographic analysis of CT scans showing accelerated bony bridging across the SI joint compared to the iFuse implant. 100% of treated SI joints showed bone integration to the iFuse-3D implant surface on both the sacral and iliac side, and 77% of treated joints showed bony bridging across the joint.
“These 24-month results from the SALLY study show that the 3D-printed iFuse-3D implant provides the same early and sustained clinical benefits as those demonstrated in two prior RCTs2,3 and one large multicenter prospective trial4 using the original iFuse implant,” said
The iFuse-3D implant is the first 3D-printed triangular titanium implant designed for fusion of the SI joint. The iFuse-3D implant has a proprietary 3D-printed surface with enhanced porosity, which mimics cancellous bone and allows for enhanced bone ongrowth and ingrowth (MacBarb 2017, Part 16). It also has a patented fenestrated structure that allows self-harvesting of bone during implant insertion that provides an excellent environment for bone through growth (MacBarb 2017, Part 27).
- 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
- Polly DW, et al. 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;10:28. DOI: 10.14444/3028
- 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
- 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;10:13. DOI: 10.14444/3013
- Patel V, et al. Prospective Trial of Sacroiliac Joint Fusion Using 3D-Printed Triangular Titanium Implants. Med Devices (Auckl). 2020;13:173-82. DOI: 10.2147/MDER.S253741
- MacBarb RF, et al. Fortifying the Bone-Implant Interface Part 1: An In Vitro Evaluation of 3D-Printed and TPS Porous Surfaces. Int J Spine Surg. 2017;11:105-15. DOI: 10.14444/4015
- MacBarb RF, et al. Fortifying the Bone-Implant Interface Part 2: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants. Int J Spine Surg. 2017;11:116-28. DOI: 10.14444/4016
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 iFuse Implant System is also intended for sacroiliac fusion to augment stabilization and immobilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. In addition, the iFuse Implant System is intended for sacroiliac fusion in 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.
Source: SI-BONE, Inc.