US-based Zyga Technology has completed the enrolment of the first four patients in the extended EVoluSIon (EVSI) Clinical Study on sacroiliac joint fusion.
The trial will involve 250 patients and will be conducted across 40 sites to assess the long-term fusion and pain reduction in patients administered with SImmetry (SI) Sacroiliac joint fusion.
SImmetry Sacroiliac joint fusion is a minimally invasive procedure which involves eliminating movement in the joint by inserting an implant and triggering bone growth by inserting a bone graft.
Deaconess Hospital in Spokane orthopedic surgeon Antoine Tohmeh said: "Minimally Invasive SI joint fusion procedures are rapidly gaining acceptance within the medical community, but it is important that the technology gives patients the best opportunity for long-term relief.
"I believe that a true fusion, including decortication, bone grafting and fixation, is critical to achieving that goal.
"Studies such as EVoluSIon are important to reinforce our knowledge and the growing base of clinical evidence for SI joint fusion."
The equipment addresses SI joint dysfunction which causes joint pains in the lower back, buttock, knees and causes pain while sitting or climbing stairs.
The Centres for Disease Control and Prevention enlisted back problems as the second most common cause of disability among the adults in US.
It has been reported that about 20% of all chronic low back pain derives from the sacroiliac joint.
Image: SI Sacroiliac Joint Fusion System design enables true fusion for lasting relief of low back pain. Photo: courtesy of PRNewsFoto / Zyga Technology, Inc.