Quality of life in preoperative patients with sacroiliac joint dysfunction is at least as depressed as in other lumbar spinal conditions

Daniel Joseph Cher, W Carlton RecklingSI-BONE, Inc., San Jose, CA, USABackground: Pain from the sacroiliac joint (SIJ) is an under-recognized cause of low back pain. The degree to which SIJ pain decreases quality of life has not been directly compared to other more familiar conditions of the lumbar spine.Methods: Multivariate regression analysis of individual patient data from two prospective multicenter clinical trials of SIJ fusion and three prospective multicenter clinical trials of surgical treatments for degenerative lumbar spine conditions.Results: Controlling for baseline demographic parameters as well as a validated disability score, quality of life scores (EuroQOL 5-D and SF-36) were, in most cases, lower in the SIJ cohorts compared to the three other spine surgery cohorts.Conclusion: Patients with SIJ dysfunction considering surgery have decrements in quality of life as or more severe compared to patients with degenerative spondylolisthesis, spinal stenosis, and intervertebral disc herniation.Keywords: spine surgery, disability, low back pain, sacroiliac joint pain, lumbar stenosis, intervertebral disc herniation, degenerative spondylolisthesis, sacroiliac joint fusio

Implant survivorship analysis after minimally invasive sacroiliac joint fusion using the iFuse Implant System®

Daniel J Cher,1 W Carlton Reckling,2 Robyn A Capobianco1 1Department of Clinical Affairs, SI-BONE, Inc., 2Department of Medical Affairs, SI-BONE, Inc., San Jose, CA, USA Introduction: Surgical revision rate is a key outcome with all permanent implants. The iFuse Implant System® is a permanent implant used to perform minimally invasive sacroiliac joint fusion. The purpose of this study is to determine the surgical revision rate after sacroiliac joint fusion surgery with this system. Methods: Using two internal sources of information, revision surgeries were identified and linked to index surgeries. The likelihood of revision surgery was calculated using the Kaplan–Meier life table approach. Predictors of revision were explored. Results: Four-year survivorship free from implant revision was 96.46%. Revision rate did not differ by sex and was lower for age >65. In all, 24% of revisions occurred within the first 30 days after surgery; 63.5% occurred within year 1. Implant survivorship has improved annually since the device was introduced in 2009. Conclusion: The survivorship rate with this implant is high and improving; the rate is somewhat higher than total hip replacement but lower than that of lumbar spine procedures. Keywords: safety, sacroiliac joint fusion, iFuse Implant System, revisio

Postmarket surveillance of 3D-printed implants for sacroiliac joint fusion

Daniel Cher,1 Kendrick Wroe,2 W Carlton Reckling,3 Scott Yerby4 1Clinical Affairs, SI-BONE, Inc., Santa Clara, CA, USA; 2Quality Assurance, SI-BONE, Inc., Santa Clara, CA, USA; 3Medical Affairs, SI-BONE, Inc., Santa Clara, CA, USA; 4Research and Development, SI-BONE, Inc., Santa Clara, CA, USA Background: Government regulations require postmarket surveillance for cleared/approved medical devices. Trend analysis of newly marketed devices may help to confirm device-related safety or uncover other device or procedure-related problems. Methods: Complaints related to the use of 3D-printed triangular titanium implants for sacroiliac joint (SIJ) fusion were compared with those of the prior machined version of the device manufactured with a titanium plasma spray (TPS) coating. Event rates were calculated either by dividing event counts by numbers of surgeries or, for late events, using Kaplan–Meier survival analysis. Results: Three types of complaints with nontrial frequencies were identified. Issues in instruments occurred at a low and constant rate (1.3%). Using Kaplan–Meier analysis, pain-related complaints occurred at a low and similar rate in both groups (<0.5%). The 1-year cumulative probability of surgical revision was low in both the 3D and machined versions of the device (1.5% for machined and 1% for 3D printed, P=0.0408 for difference). No implant breakages or migrations were identified in either group, and overall rates were similar to a previously published report. Conclusion: The 3D-printed version of triangular titanium implant was associated with complaint and adverse event rates similar to those for the prior machined version of the device. Keywords: permanent implants, quality system, complaint analysis, adverse events, postmarket surveillance, sacroiliac joint fusio