Two-year outcomes from a randomized controlled trial of minimally invasive sacroiliac joint fusion vs. non-surgical management for sacroiliac joint dysfunction

David W. Polly, John Swofford, Peter G. Whang, Clay J. Frank, John A. Glaser, Robert P. Limoni, Daniel J. Cher, Kathryn D. Wine, Jonathan N. Sembrano, John Cummings, James Cole, Elizabeth Pertile, Ellen Looney, Patti Hunker, Mary Anne Gfell, Clay Frank, Jamie Edwards, Gordon Mortensen, Tracy Mente, Scott KitchelChristopher Miller, Gregory Moore, Shawn Potts, Brett Barnes, Robert Limoni, Nilesh Patel, Taylor Romdenne, Denise Barnes, Nicholas Peterson, Harry Lockstadt, Elaine Wilhite, James Farris, Don Kovalsky, Laura Pestka, Cristy Newman, Peter Whang, Donna Ann Thomas, Bethany Samperi, Stacey Lombardi, Emily A. Darr, Laura Fields, Jennifer Philp, Monica Baczko, Charles Harvey, Jason Peterman, Karim Bouferrache, Lori Latham, Pierce Nunley, Charles Ledonio, Sharon Yson, the INSITE Study Group

Research output: Contribution to journalArticlepeer-review

80 Scopus citations


Background Sacroiliac joint (SIJ) dysfunction is an important and underappreciated cause of chronic low back pain. Objective To prospectively and concurrently compare outcomes after surgical and non-surgical treatment for chronic SIJ dysfunction. Methods One hundred and forty-eight subjects with SIJ dysfunction were randomly assigned to minimally invasive SIJ fusion with triangular titanium implants (SIJF, n=102) or non-surgical management (NSM, n=46). SIJ 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 with clinical improvement (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. Results In the SIJF group, mean SIJ pain improved rapidly and was sustained (mean improvement of 55.4 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 82.0% received either clinical improvement or substantial clinical benefit in VAS SIJ pain score. Similarly, 68.2% and 65.9% had received clinical improvement 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. Conclusions In this Level 1 multicenter prospective randomized controlled trial, 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. This study was approved by a local or central IRB before any subjects were enrolled. All patients provided studyspecific informed consent prior to participation.

Original languageEnglish (US)
Article number3028
JournalInternational Journal of Spine Surgery
Issue number2016
StatePublished - 2016

Bibliographical note

Publisher Copyright:
© 2016 ISASS.


  • Minimally invasive surgery
  • Randomized clinical trial
  • Sacroiliac joint dysfunction
  • Sacroiliac joint fusion


Dive into the research topics of 'Two-year outcomes from a randomized controlled trial of minimally invasive sacroiliac joint fusion vs. non-surgical management for sacroiliac joint dysfunction'. Together they form a unique fingerprint.

Cite this