JOURNAL ARTICLE

173 Randomized Trial of Sacroiliac Joint Fusion Using Triangular Titanium Implants vs Nonsurgical Management

Charles Frederick Harvey, Daniel Cher
Neurosurgery 2015, 62: 223
26182019

INTRODUCTION: Sacroiliac joint (SIJ) pain is a common cause of lower back and sciatic pain. Nonsurgical treatment often fails to provide pain relief. Minimally invasive SIJ fusion is now available with several devices. To date, no prospective concurrent comparison of SIJ fusion against nonsurgical treatment has been reported.

METHODS: We conducted a prospective randomized controlled trial (INSITE: NCT01681004) of 148 subjects with SIJ dysfunction assigned to SIJ fusion (iFuse Implant System, n = 102) or nonsurgical management (NSM, n = 46). Subjects underwent structured assessments at baseline and 1, 3, 6, and 12 months after treatment: SIJ pain measured with Visual Analog Scale (VAS), Oswestry Disability Index (ODI), 10 SF-36, 11 Euro-Qol-5D12, and satisfaction. Success required a decrease of VAS SIJ pain by >20 points without severe device-related or neurological adverse events and no surgical revision.

RESULTS: Subjects (70% women, mean age 51, Table 1) were highly debilitated at baseline (mean VAS SIJ pain = 82, mean ODI = 62). Six-month follow-up was obtained in 97.3% (Figure 1). By 6 months, success rates were 81.4% in the surgical group vs 23.9% in the NSM group (Table 2). VAS pain scores decreased significantly to 29.8 in the surgically treated group vs 70.4 in the nonsurgical group (Figure 2, Table 3). Clinically important ODI improvement occurred in 75% of surgery subjects vs 27.3% of NSM subjects (Figure 3). Quality of life improved in the surgery group but not the NSM group (Figure 4). No premature crossover between treatment groups was seen. The mean number of adverse events was not significantly higher in the surgical group compared with the nonsurgical group.

CONCLUSION: This level 1 study demonstrated that SIJ fusion using iFuse implants was more effective than NSM in relieving pain and disability in patients with SIJ dysfunction at 6 months. Twelve-month data will be available and presented at the meeting.

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