Six-month outcomes from a randomized controlled trial of minimally invasive SI joint fusion with triangular titanium implants vs conservative management

Abstract

Purpose To compare the safety and effectiveness of minimally invasive sacroiliac joint fusion (SIJF) using triangular titanium implants vs conservative management (CM) in patients with chronic sacroiliac joint (SIJ) pain. Methods 103 adults with chronic SIJ pain at nine sites in four European countries were randomly assigned to and underwent either minimally invasive SIJF using triangular titanium implants (N = 52) or CM (N = 51). CM was performed according to the European guidelines for the diagnosis and management of pelvic girdle pain and consisted of optimization of medical therapy, individualized physical therapy (PT) and adequate information and reassurance as part of a multifactorial treatment. The primary outcome was the difference in change in self-rated low back pain (LBP) at 6 months. Additional endpoints included quality of life using EQ-5D-3L, disability using Oswestry Disability Index (ODI), SIJ function using active straight leg raise (ASLR) test and adverse events. NCT01741025. Results At 6 months, mean LBP improved by 43.3 points in the SIJF group and 5.7 points in the CM group (difference of 38.1 points, p \ 0.0001). Mean ODI improved by 26 points in the SIJF group and 6 points in the CM group (p \ 0.0001). ASLR, EQ-5D-3L, walking distance and satisfaction were statistically superior in the SIJF group. The frequency of adverse events did not differ between groups. One case of postoperative nerve impingement occurred in the surgical group. Conclusions In patients with chronic SIJ pain, minimally invasive SIJF using triangular titanium implants was safe and more effective than CM in relieving pain, reducing disability, improving patient function and quality of life.

Fortifying the Bone-Implant Interface Part 2: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants

“…[8][9][10]41,42 Specifically, the TPS implants were found to exhibit a substantial degree of bone ongrowth and ingrowth to their surfaces, resulting in a mechanically stable interface with surrounding host bone. The AM implants investigated herein provide a highly interconnected porous surface with an open fenestrated core structure that offers comparatively greater surface area for bony integration and the ability to be pre-packed with graft material, which may benefit a number of spinal implants, such as fusion, disc, and SI joint implants.…”

“…Prospective clinical trials [8][9][10] have shown high levels of pain relief and improvement in disability scores and quality of life in patients undergoing SI joint fusion with a series of titanium plasma spray (TPS) coated triangular implants placed transarticularly across the SI joint. Computed tomography scan follow-up in the two U.S. trials have shown high rates of bone adherence to implants and signs of bridging bone across the SI joint.…”

Distraction arthrodesis of the sacroiliac joint: 2-year results of a descriptive prospective multi-center cohort study in 171 patients

“…If the frequently used threshold of 15% is used, the average decrease of 18% provides evidence for the clinical relevance in our patient population in this area as well. If the end values for VAS and ODI 24 months following posterior fusion were compared with the results recently published by Sturesson et al [34] 6 months after lateral percutaneous stabilization, comparable values are yielded ( Table 4). According to Grafton [35], the minimum detectable change in the overall score of the SF-MPQ is 8.7%, which was reached here at an observed decrease of 19% in the values after a 24-month observation period.…”

ISASS Policy 2016 Update – Minimally Invasive Sacroiliac Joint Fusion

“…In contrast, mean ODI decreased by only 4.6 points in the nonsurgical group. In the European randomized trial, 18 Mean pain scores improved in the SIJ fusion group from 77.7 at baseline to 34.4 at 6 months (a 43.3 point improvement p<.0001) vs. 73.0 to 67.8 (an improvement of 5.7 points, p=.1105) in the non-surgical group. ODI improved by 20 points more in the surgical vs. non-surgical groups 9p<.0001).…”

“…17 Responses in the non-surgical arms of two prospective randomized trials showed little, if any, improvement at 6 months. 18,19 Given the absence of published outcomes data supporting long-term pain relief from non-surgical treatment, patients with a diagnosis of SIJ pain who experience pain for a minimum of six months and who do not respond to an adequate course of non-surgical treatment may be considered for SIJ fusion.…”