The three pooled trials are prospective clinical trials of SIJF with TTI. Trial characteristics are presented in Table 1 . Literature searches using Medline, Embase, and ClinicalTrials.gov [primary search terms: sacroiliac joint AND (arthrodesis OR fusion)] revealed no other ongoing prospective TTI trials.
INSITE, a prospective 2-year multicenter randomized controlled trial (RCT) conducted at 19 centers in the US,28 included 148 patients with diagnosed SIJ dysfunction unresponsive to at least 6 months of conservative care. Patients were included between January 2013 and May 2014. Diagnosis was based on history, physical examination tests,38 (link) and a ≥50% decrease in SIJ pain after image-guided joint block with local anesthetic.39 (link)–42 (link) Subjects were randomized in a 2:1 fashion to either SIJF as previously described35 or NSM. NSM included anti-inflammatory and opioid pain medications, physical therapy, intra-articular SIJ steroid injections, and radiofrequency neurotomy, delivered serially as needed to manage pain and disability. Assessments included SIJ pain using a visual analog scale, Oswestry Disability Index (ODI),43 (link) EuroQoL-5D (EQ-5D),44 and Short Form-36 (SF-36).45 (link) In the NSM group, crossover to surgical care was allowed only after the 6-month visit was complete.
iMIA, a prospective multicenter randomized controlled clinical trial (n = 103), was conducted at nine European centers.36 (link) Patients were included between June 2013 and May 2015. Key differences between iMIA and INSITE include 1) iMIA used 1:1 randomization, 2) nonsurgical treatment in iMIA included only physical therapy per European guidelines,46 (link) 3) iMIA included Zung Depression Scale47 (link) but not SF-36, and 4) iMIA included a functional test48 (link) and self-reported walking distance.
SIFI is a prospective, multicenter, single-arm clinical trial (n = 172) conducted at 26 centers in the US.37 Patients were included between August 2012 and December 2013. All subjects underwent SIJF. SIFI subjects underwent computed tomography (CT) scan at 1 year; otherwise, study parameters were identical to INSITE.
INSITE, a prospective 2-year multicenter randomized controlled trial (RCT) conducted at 19 centers in the US,28 included 148 patients with diagnosed SIJ dysfunction unresponsive to at least 6 months of conservative care. Patients were included between January 2013 and May 2014. Diagnosis was based on history, physical examination tests,38 (link) and a ≥50% decrease in SIJ pain after image-guided joint block with local anesthetic.39 (link)–42 (link) Subjects were randomized in a 2:1 fashion to either SIJF as previously described35 or NSM. NSM included anti-inflammatory and opioid pain medications, physical therapy, intra-articular SIJ steroid injections, and radiofrequency neurotomy, delivered serially as needed to manage pain and disability. Assessments included SIJ pain using a visual analog scale, Oswestry Disability Index (ODI),43 (link) EuroQoL-5D (EQ-5D),44 and Short Form-36 (SF-36).45 (link) In the NSM group, crossover to surgical care was allowed only after the 6-month visit was complete.
iMIA, a prospective multicenter randomized controlled clinical trial (n = 103), was conducted at nine European centers.36 (link) Patients were included between June 2013 and May 2015. Key differences between iMIA and INSITE include 1) iMIA used 1:1 randomization, 2) nonsurgical treatment in iMIA included only physical therapy per European guidelines,46 (link) 3) iMIA included Zung Depression Scale47 (link) but not SF-36, and 4) iMIA included a functional test48 (link) and self-reported walking distance.
SIFI is a prospective, multicenter, single-arm clinical trial (n = 172) conducted at 26 centers in the US.37 Patients were included between August 2012 and December 2013. All subjects underwent SIJF. SIFI subjects underwent computed tomography (CT) scan at 1 year; otherwise, study parameters were identical to INSITE.
