Long-term prospective outcomes after minimally invasive trans-iliac sacroiliac joint fusion using triangular titanium implants

Abstract

BackgroundMinimally invasive sacroiliac joint fusion (SIJF) has become an increasingly accepted surgical option for chronic sacroiliac (SI) joint dysfunction, a prevalent cause of unremitting low back/buttock pain.ObjectiveThe objective of this study was to report clinical and functional outcomes of SIJF using triangular titanium implants (TTI) in the treatment of chronic SI joint dysfunction due to degenerative sacroiliitis or sacroiliac joint (SIJ) disruption at 3 years postoperatively.MethodsA total of 103 subjects with SIJ dysfunction at 12 centers were treated with TTI in two prospective clinical trials (NCT01640353 and NCT01681004) and enrolled in this long-term follow-up study (NCT02270203). Subjects were evaluated in study clinics at study start and again at 3, 4, and 5 years.ResultsMean (SD) preoperative SIJ pain score was 81.5, and mean preoperative Oswestry Disability Index (ODI) was 56.3. At 3 years, mean pain SIJ pain score decreased to 26.2 (a 55-point improvement from baseline, p<0.0001). At 3 years, mean ODI was 28.2 (a 28-point improvement from baseline, p<0.0001). In all, 82% of subjects were very satisfied with the procedure at 3 years. EuroQol-5D (EQ-5D) time trade-off index improved by 0.30 points (p<0.0001). No adverse events definitely related to the study device or procedure were reported; one subject underwent revision surgery at year 3.7. SIJ pain contralateral to the originally treated side occurred in 15 subjects of whom four underwent contralateral SIJF. The proportion of subjects who were employed outside the home full- or part-time at 3 years decreased somewhat from baseline (p=0.1814), and the proportion of subjects who would have the procedure again was lower at 3 years compared to earlier time points.ConclusionIn long-term (3-year) follow-up, minimally invasive trans-iliac SIJF with TTI was associated with improved pain, disability, and quality of life with relatively high satisfaction rates.Level of evidenceLevel II.Clinical relevanceSIJF with TTI.

Sacroiliac Joint Fusion: Approaches and Recent Outcomes

“…This study is again sponsored by SI‐Bone. A preliminary report on the 3‐year results has recently been published, showing essentially that the good surgical outcomes reported at 2 years were maintained at 3 years . Another study reported on the 2‐year results of distraction arthrodesis in 20 centers in Germany.…”

<p>Minimally invasive lateral transiliac sacroiliac joint fusion using 3D-printed triangular titanium implants</p>

“…Herein we report outcomes of the first 28 subjects with 6-month data; the study is fully enrolled and long-term follow-up is ongoing. On the basis of prior prospective randomized and single-arm trials, responses at 3–6 months predict long-term (2-,6 3-,22 and 4-year23) responses to SIJF using the prior version of the device, justifying this early report of patient outcomes.…”

“…Previous prospective randomized trials6,8 and other prospective7,22,23 and retrospective9–14,32 studies have demonstrated that SIJF with iFuse Implant System, a milled solid triangular titanium implant with a spray-coated surface, is safe and effective for the treatment of chronic SIJ dysfunction related to degeneration or disruption of the SIJ. The current study confirms that the newer 3D-printed version of the device provides similar improvements in pain, disability and quality of life along with similarly high satisfaction rates in the same patient population compared to studies of the prior device version.…”

Biomechanical Stability of Primary and Revision Sacroiliac Joint Fusion Devices: A Cadaveric Study

“…[3][4][5] It is often noted that SIJ diagnosis is one of the more sensitive and specific diagnoses for low back pain, and fusion procedures have been associated with improved pain, disability, and quality of life with relatively high satisfaction rates. 6,7 The mechanism of pain relief with these surgical techniques is thought to be two-fold with early pain relief as a result of immediate surgical joint stabilization and late pain relief as a result of fusion. 8 Fixation and fusion procedures are generally seen as a last resort for patients experiencing SIJ pain as nonoperative management consisting of physical therapy and rehabilitation is often undertaken first.…”