Subjects are being asked to volunteer for this research study because your doctor feels that there is a significant probability that your sacroiliac joint (SIJ) contributes to your back pain and that you may be a candidate for sacroiliac surgery. If you meet the study requirements you will have a surgical procedure to have SImmetry devices implanted in your body.The SImmetry Sacroiliac Joint Fusion System is a device approved by the U.S. Food and Drug Administration (FDA).
This study will collect data to better understand pain reduction on your sacroiliac joint (low back/buttock) after implantation of the SImmetry Sacroiliac Joint Fusion device. Subjects will complete a total of 5 visits over the course of 2 years.
The primary endpoints of the investigation will include assessment of the maintenance of disc height and fusion rates demonstrated by radiographic evidence based on plain radiographs and CT. Fusion is defined as a bone bridging across the disc space at the level of the InterFuse T™ implant. Length of stay, implant migration, implant subsidence, reoperation rate, and Opiod use will be recorded. It is anticipated that outcomes with the InterFuse T™ Interbody Fusion Device will be comparable to or better than the historical published results for other non-modular TLIF devices, and to the control device used concurrently in this study.