Clinical Data
Multicenter, 1-year Follow-up (Sachs - MDER 2014)
One-year Outcomes After Minimally Invasive Sacroiliac Joint Fusion with a Series of Triangular Implants: A Multicenter, Patient-level Analysis
Sachs D, Capobianco R, Cher D, Holt T, Gundanna M, Graven T, Shamie AN, Cummings J Jr.
Med Devices (Auckl). 2014;7:299–304. DOI: 10.2147/MDER.S56491. PMCID: PMC4155989
Abstract
Background: Sacroiliac joint (SI) pain is an often-overlooked cause of lower-back pain, due in part to a lack of specific findings on radiographs and a symptom profile similar to other back-related disorders. A minimally invasive surgical (MIS) approach to SI joint fusion using a series of triangular, titanium plasma spray-coated implants has shown favorable outcomes in patients with SI joint pain refractory to conservative care. The aim of this study was to provide a multicenter experience of MIS SI joint fusion using a patient-level analysis.
Patients and methods: We report a patient-level analysis from 144 patients with a mean of 16 months postoperative follow-up. Demographic information, perioperative measures, complications, and clinical outcomes using a visual analog scale for pain were collected prospectively. Random-effects regression models were used to account for intersite variability.
Results: The mean age was 58 years, 71% of patients were female, and 62% had a history of lumbar spinal fusion. Mean (95% confidence interval [CI]) operative time was 73 minutes (25.4–118), blood loss was minimal, and hospital stay was 0.8 days (0.1–1.5). At follow-up, mean (95% CI) visual analog scale pain scores improved by 6.1 points (5.7–6.6). Substantial clinical benefit, defined as a decrease in pain by .2.5 points or a score of 3.5 or less, was achieved in 91.9% of patients (95% CI 83.9%–96.1%), and 96% (95% CI 86.3%–98.8%) of patients indicated they would have the same surgery again.
Conclusion: When conservative measures fail to relieve symptoms resulting from degeneration or disruption of the SI joint, MIS SI joint fusion using a series of triangular, porous, titanium plasma spray-coated implants is a safe and effective treatment option.
Keywords: minimally invasive surgery, sacroiliac joint, SI joint fusion, arthrodesis, previous spine surgery
List of authors:
Donald Sachs* - Center for Spinal Stenosis and Neurologic Care, Lakeland, FL,
Robyn Capobianco - SI-BONE, Inc., San Jose, CA,
Daniel Cher - SI-BONE, Inc., San Jose, CA,
Timothy Holt* - Montgomery Spine Center, Montgomery, AL,
Mukund Gundanna* - Brazos Spine, College Station, TX,
Timothy Graven* -SSM Orthopedics, Wentzville, MO,
A. Nick Shamie** – UCLA Spine Center, Santa Monica, CA,
John Cummings Jr* -Community Neurosurgical
* Paid consultant and conducts clinical research for SI-BONE Inc.
** Paid consultant and ownership interest in SI-BONE Inc.