SI-BONE, Inc. Announces Publication of iFuse-3D Implant Clinical Study Results Showing Accelerated Fusion, Immediate and Sustained Clinical Improvements and Reduction in Opioid Use
Novel, proprietary drug candidate has shown therapeutic potential in extensive preclinical studies
SANTA CLARA, Calif., July 07, 2021 (GLOBE NEWSWIRE) -- SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to solving musculoskeletal disorders of the sacropelvic anatomy announced the publication of 2-year results from SALLY (Study of bone growth in the Sacroiliac Joint after Minimally Invasive Surgery with Titanium Implants, ClinicalTrials.gov NCT 03122899)1, a prospective multicenter clinical trial of the iFuse-3D™ Implant System. Clinical results at 24 months showed marked and sustained improvements in sacroiliac (SI) joint pain, patient function and quality of life that are consistent with results from three prior multicenter prospective clinical trials using the iFuse implant (RCT INSITE 2-year2, RCT iMIA 2-year3, SIFI 2-year4). Results also demonstrated a significant reduction in the proportion of study subjects taking opioids for SI joint pain (59% at baseline to 18% at 24 months). In addition, the study included three objective physical function tests (active straight leg raise, five times sit-to-stand and transitional timed up-and-go), all of which showed statistically significant improvements from baseline.
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 Vikas Patel, MD., Department of Orthopedics at University of Colorado and study principal investigator. “Furthermore, the early results from radiographic analysis of implant bone integration and SI joint bony bridging indicate that the enhanced porous surface of the iFuse-3D implant combined with the fenestrated structural design accelerates the rate of intraarticular fusion compared to the iFuse implant.”
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
About SI-BONE, Inc.
SI-BONE is a medical device company that pioneered minimally invasive surgery of the SI joint with the iFuse Implant System®. Studies have shown that the SI joint can be a source of pain in 15% to 30% of chronic low back pain. The iFuse implant, commercially available since 2009, is the only SI joint fusion device supported by multiple prospective clinical studies, including two randomized controlled trials, showing improved pain, patient function and quality of life resulting from treatment. There are over 95 peer-reviewed publications demonstrating the safety, durable effectiveness, and biomechanical and economic benefits unique to the iFuse implant (www.si-bone.com/results). This body of evidence has enabled multiple government and private insurance payors to establish coverage of the SI joint fusion procedure exclusively when performed with the iFuse Implant System.
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.
SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2021 SI-BONE, Inc. All Rights Reserved.
Matt Bacso, CFA