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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, MD,1 John Swofford, MD,2 Peter G. Whang, MD,3 Clay J. Frank, MD,4 John A. Glaser, MD,5 Robert P. Limoni, MD,6 Daniel J. Cher, MD,7 Kathryn D. Wine, MPH,7 Jonathan N. Sembrano, MD,8 and the INSITE Study Group.

1Departments of Orthopedic Surgery and Neurosurgery, University of Minnesota, Minneapolis, MN 2Indiana Interventional Pain, Indiana Surgery Center East, Indianapolis, IN 3Department of Orthopaedics and Rehabilitation, Yale University School of Medicine, New Haven CT 4Integrated Spine Care, Wauwatosa, WI 5Medical University of South Carolina,  Charleston, SC 6Aurora BayCare Orthopedic & Sports Medicine Center,  Green Bay, WI 7SI-BONE, Inc., San Jose, CA 8Department of Orthopaedic Surgery, University of Minnesota, Minneapolis, MN

Abstract

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 study-specific informed consent prior to participation.

keywords: 
sacroiliac joint dysfunction, sacroiliac joint fusion, Minimally invasive surgery, randomized clinical trial
Volume 10 Article 28
doi: 
10.14444/3028