Record Status This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database. Citation HAYES, Inc. iFuse implant system (SI-Bone Inc.) for sacroiliac joint fusion for treatment of low back pain. Lansdale: HAYES, Inc. Healthcare Technology Brief Publication. 2016 Authors' objectives The sacroiliac joint (SIJ) has been implicated as the primary source of pain in 10% to 30% of patients with chronic low back pain. SIJ dysfunction is characterized by the malalignment or abnormal movement of the SIJ.
Description of Technology: The iFuse Implant System was developed for minimally invasive SIJ fusion in patients who have not experienced adequate relief from nonsurgical management. The iFuse system consists of sterile, rigid titanium rods that are designed to minimize joint rotation, maximize joint surface area, and facilitate biologic fixation to bone. Using general anesthesia, fluoroscopic guidance, and a small incision, an orthopedic or neurologic surgeon places a series of 2 to 4 implants (typically 3) across the SIJ. No bone grafting is required.
Patient Population: The iFuse Implant System is indicated for use in patients with SIJ dysfunction that is a direct result of SIJ disruption and degenerative sacroiliitis.
Clinical Alternatives: Alternatives to SIJ fusion using minimally invasive surgery with iFuse implants include
nonsurgical methods such as physical therapy, medications (including anti-inflammatory agents), pelvic/sacroiliac belts, chiropractic management, intra-articular or periarticular steroid or anesthesia injections, or radiofrequency ablation of the lateral branches of the sacral nerve roots (neurotomy). Alternative surgical methods include open or minimally invasive SIJ fusion employing devices other than iFuse implants. Indexing Status Subject indexing assigned by CRD MeSH Arthrodesis; Back; Bone and Bones; Humans; Low Back Pain; Sacroiliac Joint; Spinal Diseases Language Published English Country of organisation United States English summary An English language summary is available. Address for correspondence HAYES, Inc., 157 S. Broad Street, Suite 200, Lansdale, PA 19446, USA. Tel: 215 855 0615; Fax: 215 855 5218 Email: hayesinfo@hayesinc.com AccessionNumber 32017000072 Date abstract record published 06/01/2017 |