US-based medical device company SI-Bone has reported positive results of the Investigation of Sacroiliac Fusion Treatment (INSITE) study of its iFuse Implant System compared with non-surgical management (NSM) for Sacroiliac Joint Dysfunction.
The iFuse Implant System is designed as a minimally invasive surgical option that uses titanium implants with a porous surface acting as an interference surface, to help decrease implant motion, and facilitate biological fixation to support long term fusion.
The device is intended to be used for sacroiliac fusion for conditions namely sacroiliac joint dysfunction, which is directly attributed to sacroiliac joint disruption and degenerative sacroiliitis.
The INSITE study was designed as a prospective, multicentre, randomised controlled trial which involved 148 patients, out of who, 102 patients were treated with iFuse device while the rest were treated with the NSM.
Results suggested that the iFuse group experienced reduction in their joint pain with a decrease in disability determined on the basis of Oswestry Disability Index (ODI).
Rush University Medical Center in Chicago MD Frank Phillips said: "These two-year results from the INSITE study illustrate the durability of SI joint fusion with iFuse and further validate previously reported 6- and 12-month results that showed rapid improvement in pain, function and quality of life in this highly debilitated patient population.
"This positive publication validates the consistency of the earlier publications on iFuse and will hopefully encourage health plans across the US to establish coverage for this effective procedure."
Clinical studies that were conducted earlier have also demonstrated the efficacy of the iFuse Implant System in improving pain, patient function, and quality of life.
Image: Graphical illustration of study results of iFuse Implant System. Photo: courtesy of PRNewsFoto/SI-BONE, Inc.