Sacroiliac joint fusion likely more effective than nonsurgical management

NEW ORLEANS — Substantial improvements were seen in VAS scores at 6 months and were sustained through 12 months postoperatively among patients randomized to undergo sacroiliac joint fusion using a titanium triangular implant, according to results of a level 1 study presented here.

“This study provides the first level 1 evidence in support of minimally invasive sacroiliac fusion,”

Charles Frederick Harvey, MD, said at the Congress of Neurological Surgeons Annual Meeting.

Researchers compared the results of surgical patients with sacroiliac (SI) arthritis or joint disruption to that of similar patients who were randomized to nonsurgical management alone.

Charles Frederick Harvey

Overall, 148 patients were enrolled in the study between August 2012 and May 2014 and were randomized 2:1. This resulted in 100 patients who underwent minimally invasive SI joint fusion with the i-Fuse Implant System (SI-BONE Inc.) within 30 days of diagnosis of SI joint dysfunction and 48 patients who received 6 months of best medical management.

“Nonsurgical management, in all cases, included medical optimization and outpatient physical therapy,” he said.

According to Harvey, the aim of the trial was to prove the value of minimally invasive surgery (MIS) SI fusion. A planned part of the trial was that, after 6 months of nonsurgical management, patients in that group could crossover to the surgical treatment group.

“The SI fusion group shows marked improvement at 6 months and 12 months,” Harvey said.

Improvements seen in the surgical patients were reflected in results of all the tests they underwent, which included tests for mental health and emotional function, he said.

The follow-up in the study at 12 months was 96% in the surgical group and 87% in the nonsurgical group, according to Harvey.

“This prospective multicenter randomized trial has some limitations. It was industry-sponsored, number one, but most spine surgery device trials are. Number two: We await 2-year data, which will include a CT of the pelvis,” Harvey said. “Also, the high planned crossover rate at 6 months does prevent some direct, long-term comparisons between groups.” – by Susan M. Rapp

Reference:

Harvey CF, et al. Paper #173. Presented at: Congress of Neurological Surgeons Annual Meeting; Sept. 26-30, 2015; New Orleans.

Disclosure: Harvey reports he is a consultant to SI-BONE and this research trial was supported by SI-BONE.