Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion Using Triangular Titanium Implants vs. NonSurgical Management for Sacroiliac Joint Dysfunction

Abstract

Introduction Sacroiliac (SI) joint dysfunction is a prevalent cause of unremitting low back pain. Does minimally invasive SIJ fusion provide superior outcomes compared with nonsurgical treatment? Methods 148 subjects with SI joint dysfunction were randomly assigned at 19 US centers to minimally invasive SI joint fusion with triangular titanium implants (N = 102) or nonsurgical management (NSM, n = 46). Pain, disability and quality of life scores were collected at baseline and at 1, 3, 6 and 12 months. Success rates were compared using Bayesian methods. Crossover from nonsurgical to surgical care was allowed after the 6month study visit was complete. Results Sixmonth success rates were higher in the surgical group (81.4% versus 26.1%, posterior probability of superiority > 0.9999). Clinically important (≥15 point) ODI improvement at 6 months occurred in 73.3% of the SIJ fusion group versus 13.6% of the NSM group (p < 0.0001). Improvements in SIJ pain and ODI were sustained at 12 months in the surgical group. Subjects who crossed over had improvements in pain, disability and quality of life similar to those in the original surgical group. Adverse events were slightly more common in the surgical group (1.3 versus 1.1 events per subject, p = 0.3063). One patient underwent immediate revision surgery for neuropathic pain related to implant malposition. 77 and 78% of subjects assigned to SIJ fusion were “very satisfied” with SIJ fusion at 6 and 12 months, respectively. Conclusions In this study, minimally invasive SI joint fusion using triangular titanium implants was more effective than nonsurgical management at one year in relieving pain, improving function and improving quality of life in patients with SI joint dysfunction.

Navigating the Murk: Ethical and Practical Considerations for the Surgical Treatment of the Sacroiliac Joint Syndrome

“…Rudolf, 43 in a retrospective study, report improvement of postoperative pain scores of 70% to 85% at 1 year after unilateral joint fusion in 46 patients treated for chronic degenerative sacroiliitis or SI joint disruption using an immediate reduction of ≥ 75% in Visual Analog Scale pain scales after image-guided diagnostic block, history, and examination. Similarly, a large industry-funded case control series by Polly et al 45 reports 81.4% of surgical patients report improvement in pain scores of ≥ 2 mm on the Visual Analog Scale at 6 months and 83% of surgical patients report the same improvement at 24 months. 46 The inclusion criteria for the Polly trial are a source of controversy as there were no SI joint structural criteria, the intra-articular injection inclusion criteria of "at least a 50% transient decrease in SIJ pain 30 to 60 minutes after image-guided local anesthetic injection into the SIJ," do not match what has been published in the literature (discussed above), 37,38 and the clinical diagnosis was nonspecific.…”

“…Frank discussion and informed consent between the clinician and the patient undergoing evaluation for SI joint surgery is imperative. That discussion should include the reality that the diagnostic criteria is still debated; that the surgical results are not entirely predictable; that there are few data available about the efficacy of this procedure that is not industry sponsored; that perioperative complications profiles can be high with a high learning curve-20% in 1 series 43 ; that the most comprehensive case control trial (industry sponsored) had minimal subjective pain reduction as a measure of efficacy 45,46 ; and that the clinical data are variable with some studies report worsening of symptoms (which highlights the fact that not all SI surgeries are the same). 47 Exercise of caution and restraint are in order when recommending this unvalidated procedure.…”

Persistent Iliosacral Joint Syndrome following Instrumentation to the Sacropelvis in Patients with Adult Spinal Deformity

“…[63][64][65][66][67][68] There still is a paucity of surgical outcomes data regarding SIJ arthrodesis in patients affected by PSIJS after lumbar/lumbosacral fusion surgery, with long-term clinical success rates reported to reach up to 70%. [64][65][66][67][68][69]…”

“…Secondary ISF led to a highly significant reduction of SIJ pain in eight of nine affected individuals, in keeping with the results of a 2015 randomized controlled trial reporting on surgical outcomes of SIJ fusion, including a high percentage of patients with previous lumbar/lumbosacral fusion. 69 However, more long-term data are required to allow definitive conclusions. Despite the fact that degenerative SIJ alterations are found in $ 25% of asymptomatic patients > 50 years of age, 62,77 preexisting SIJ arthrosis (as demonstrated by CT) as well as hip arthrosis were identified as significant independent predictors of PSIJS, underscoring the need for comprehensive preoperative clinical assessment and treatment of symptomatic hip arthrosis before ASDS.…”

Klinische Studie zur Prüfung des iFuse Implant Systems® bei Patienten mit Iliosakralgelenksyndrom: 1-Jahres-Ergebnisse

“…Zur Beurteilung eines neuen minimalinvasiven Operationsverfahrens hinsichtlich Anwendbarkeit, Wirksamkeit über 1 Jahr und Verträglichkeit wurden Untersuchungen an Patienten, die sich konservativen Behandlungsmaßnahmen gegenüber als refraktär erwiesen hatten, durchgeführt. Zur Anwendung kam das "iFuse Implant System ® " der Firma SI-Bone, das sich in vorausgegangenen Studien als sicher und wirksam erwiesen hatte [20][21][22].…”