Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: A Prospective Study

Bradley S Duhon, Daniel J Cher, Kathryn D Wine, Don A Kovalsky, Harry Lockstadt, SIFI Study Group, Bradley S Duhon, Daniel J Cher, Kathryn D Wine, Don A Kovalsky, Harry Lockstadt, SIFI Study Group

Abstract

Study Design Prospective multicenter single-arm interventional clinical trial. Objective To determine the degree of improvement in sacroiliac (SI) joint pain, disability related to SI joint pain, and quality of life in patients with SI joint dysfunction who undergo minimally invasive SI joint fusion using triangular-shaped titanium implants. Methods Subjects (n = 172) underwent minimally invasive SI joint fusion between August 2012 and January 2014 and completed structured assessments preoperatively and at 1, 3, 6, and 12 months postoperatively, including a 100-mm SI joint and back pain visual analog scale (VAS), Oswestry Disability Index (ODI), Short Form-36 (SF-36), and EuroQOL-5D. Patient satisfaction with surgery was assessed at 6 and 12 months. Results Mean SI joint pain improved from 79.8 at baseline to 30.0 and 30.4 at 6 and 12 months, respectively (mean improvements of 49.9 and 49.1 points, p < 0.0001 each). Mean ODI improved from 55.2 at baseline to 32.5 and 31.4 at 6 and 12 months (improvements of 22.7 and 23.9 points, p < 0.0001 each). SF-36 physical component summary improved from 31.7 at baseline to 40.2 and 40.3 at 6 and 12 months (p < 0.0001). At 6 and 12 months, 93 and 87% of subjects, respectively, were somewhat or very satisfied and 92 and 91%, respectively, would have the procedure again. Conclusions Minimally invasive SI joint fusion resulted in improvement of pain, disability, and quality of life in patients with SI joint dysfunction due to degenerative sacroiliitis and SI joint disruption.

Keywords: degenerative sacroiliitis; minimally invasive surgery; prospective clinical trial; sacroiliac joint; sacroiliac joint arthrodesis; sacroiliac joint disruption; sacroiliac joint dysfunction; spine surgery.

Conflict of interest statement

Disclosures Bradley S. Duhon, Paid consultant: SI-BONE; Research grant: SI-BONE Daniel J. Cher, Employee: SI-BONE Kathryn D. Wine, Employee: SI-BONE Don A. Kovalsky, Research grant: SI-BONE Harry Lockstadt, Paid consultant: SI-BONE; Research grant: SI-BONE

Figures

Fig. 1
Fig. 1
(A) Intraoperative fluoroscopic images showing postplacement outlet (left), inlet (right), and lateral (lower) views. (B) iFuse implant (SI-BONE, Inc., San Jose, California, United States).
Fig. 2
Fig. 2
Pain location in subjects reporting primarily left-sided sacroiliac joint pain. Dot size is proportional to the number of subjects reporting pain in that location.
Fig. 3
Fig. 3
Patient flow. Some subjects who missed the 1- or 3-month visit returned for subsequent visits (dashed lines).
Fig. 4
Fig. 4
Improvement in VAS SI joint pain (A) and Oswestry Disability Index (B). Abbreviations: SE, standard error; SIJ, sacroiliac joint; VAS, visual analog scale.
Fig. 5
Fig. 5
Improvement in SF-36 domains at 6 months compared with baseline. All p < 0.0001 versus baseline except for GH (p = 0.0063 for 6 months versus baseline and p = 0.0031 for 12 months versus baseline). Solid line = baseline; dotted line = month 6; dashed line = month 12. Abbreviations: SF-36, Short Form-36; SE, standard error; BP, bodily pain; GH, general health; MH, mental health; PF, physical function; RE, role emotional; RP, role physical; SF, social function; VT, vitality.

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