Two-year outcomes from a randomized controlled trial of minimally invasive sacroiliac joint fusion vs. non-surgical management for sacroiliac joint dysfunction
Polly DW, Swofford J, Whang PG, et al. Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction. Int J Spine Surg. 2016;10:28. DOI: 10.14444/3028
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
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.