NICE Guidance Supports Use of Minimally Invasive SI Joint Fusion for Chronic Sacroiliac Pain

National Institute for Health and Care Excellence (NICE) Interventional Procedures Guidance

The National Institute for Health and Care Excellence (NICE) released their Interventional Procedures Guidance in April 2017 recommending use of minimally invasive sacroiliac (SI) joint fusion surgery for chronic sacroiliac pain in patients with confirmed diagnosis of unilateral or bilateral SI joint dysfunction due to degenerative sacroiliitis or SI joint disruption.

The guidance is based on a review of effectiveness and safety data from clinical trials of minimally invasive SI joint fusion, and the only
product used in the evaluation with an FDA clearance for SI joint fusion was SI-BONE’s iFuse Implant System®.

data analysis, calculator, magnifying glass"We decided that we would need to invest a lot of energy and time into clinical evidence to use for provider and payer education"“When we started SI-BONE, there was little clinical data on SI joint dysfunction, and we decided that we would need to invest a lot of energy and time into clinical evidence to use for provider and payer education," said Jeffrey Dunn, President and Chief Executive Officer of SI-BONE. “In fact, there are now over 50 peer-reviewed publications on the iFuse Implant System®.”

“We believe these publications coupled with the NICE Interventional Procedures guidance may help increase the proportion of health insurance companies in the United States that cover the iFuse Implant™,” Mr. Dunn said. “In addition, the findings may allow payors to make coverage decisions with more confidence given that the iFuse Implant System has gone through this kind of peer-reviewed scrutiny and rigor.”

Proper Surgical Training is Essential
In addition, NICE recommends that the procedure be performed using a lateral transarticular approach, and should be performed only by surgeons who regularly use image-guided surgery for implant placement and who have undergone specific training and have expertise in minimally invasive SI joint fusion surgery.

Mr. Dunn said that surgeons who use the iFuse Implant System are required to complete a rigorous training program to have access to the product. The program includes both a thorough didactic session and a cadaveric training.

“Many spine surgeons are helped by SI joint landmark education, because they do not receive a lot of training on this area in medical school,” Mr. Dunn said. “In addition, we teach spine surgeons to become proficient at performing provocative hands-on diagnostic tests that stress the joint as well as the importance of SI joint injections to confirm the diagnosis. The final component of training is the surgical procedure.”

Surgery Is An Option For Patients Who Fail Conservative Treatments
“SI joint fusion surgery is a viable option for carefully selected patients. If patients can be successfully treated with physical therapy, injections, radiofrequency ablation, or analgesic agents, they should not have surgery. But if patients have debilitating chronic pain despite nonsurgical care, SI joint fusion may be an effective option that, in many cases, can deliver lasting relief.”

He added that it is important to set appropriate patient expectations regarding outcomes of SI joint fusion. “If patients have complicated pathology with multiple pain generators, including having undergone previous lumbar surgeries, SI joint fusion may not completely resolve all the pain, but may significantly improve pain, patient function and quality of life.”

Updated on: 02/08/18
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