Clinical Data
INSITE 2-Year Results (Polly - IJSS 2016)
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, Frank CJ, Glaser JA, Limoni RP, Cher DJ, Wine KD, Sembrano JN, and the INSITE Study Group.
Int J Spine Surg. 2016;10:Article 28. DOI: 10.14444/3028
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
Disclosure: One or more of the individuals named herein may be a past or present SI-BONE employee, paid consultant, investor, clinical trial investigator, or grant recipient. David W. Polly is an investigator on a clinical research study sponsored by SI-BONE. He has no financial interest in SI-BONE. Research described herein was supported in whole or in part by SI-BONE.