Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction
Presented at SMISS Annual Forum 2016
By John Glaser MD
With Jonathan Sembrano MD, David Polly MD, John Swofford DO, Peter Whang MD, Clay Frank MD, Charles Harvey MD, Harry Lockstadt MD, Robert Limoni MD, Don Kovalski MD, Daniel Cher MD, Kathryn Wine MPH,
Disclosures: John Glaser MD None Jonathan Sembrano MD A; NuVasive, Inc - PI for an RCT comparing MAS-TLIF vs XLIF, SI Bone Inc., David Polly MD None, John Swofford DO B; SI Bone Inc., Peter Whang MD A; SI Bone Inc. B; SI Bone Inc., Clay Frank MD A; SI Bone Inc. B; SI Bone Inc., Charles Harvey MD B; SI Bone Inc., Harry Lockstadt MD B; SI Bone inc., Robert Limoni MD A; SI Bone Inc. B; SI Bone Inc., Don Kovalski MD None, Daniel Cher MD E; SI Bone Inc. , Kathryn Wine MPH E; SI Bone Inc.,
Sacroiliac (SI) joint dysfunction is an important and underappreciated cause of chronic low back pain.
To prospectively and concurrently compare outcomes after surgical and non-surgical treatment for chronic
SI joint dysfunction.
148 subjects with SI joint dysfunction were randomly assigned to minimally invasive SI joint fusion with triangular titanium implants (SIJF, n=102) or non-surgical management (NSM, n=46). SI joint pain (measured with a 100-point visual analog scale, VAS), disability (measured with Oswestry Disability Index, ODI) and quality of life scores were collected at baseline and at scheduled visits to 24 months. Crossover from non-surgical to surgical care was allowed after the 6-month study visit was complete. Improvements in continuous measures were compared using repeated measures analysis of variance. The proportions of subjects achieving benefit (SIJ pain improvement ≥20 points, ODI ≥15 points) and substantial clinical benefit (SIJ pain improvement ≥25 points or SIJ pain rating ≤35, ODI ≥18.8 points) were compared.
In the SIJF group, mean SIJ pain improved rapidly and was sustained (mean improvement of 56.0 points) at month 24. The 6-month mean change in the NSM group (12.2 points) was substantially smaller than that in the SIJF group (by 38.3 points, p<.0001 for superiority). By month 24, 83.1% and 81.9% received either benefit or substantial clinical benefit in VAS SIJ pain score. Similarly, 68.7% and 66.3% had received benefit or substantial clinical benefit in ODI score at month 24. In the NSM group, these proportions were <10% with non-surgical treatment only. Parallel changes were seen for EQ-5D and SF-36, with larger changes in the surgery group at 6 months compared to NSM. The rate of adverse events related to SIJF was low and only 3 subjects assigned to SIJF underwent revision surgery within the 24-month follow-up period.
In this Level 1 multicenter prospective randomized controlled study, minimally invasive SIJF with triangular titanium implants provided larger improvements in pain, disability and quality of life compared to NSM. Improvements after SIJF persisted to 24 months.