Clinical Data
iMIA 6-month Results (Sturesson - Eur Spine J 2016)
Six-month Outcomes from A Randomized Controlled Trial of Minimally Invasive SI Joint Fusion with Triangular Titanium Implants vs Conservative Management
Sturesson B, Kools D, Pflugmacher R, Gasbarrini A, Prestamburgo D, Dengler J.
Eur Spine J. 2017;26(3):708–19. [Epub 2016 May 14].
DOI: 10.1007/s00586-016-4599-9
ABSTRACT
Purpose: To compare the safety and effectiveness of minimally invasive sacroiliac joint fusion (SIJF) using triangular titanium implants vs conservative management (CM) in patients with chronic sacroiliac joint (SIJ) pain.
Methods: 103 adults with chronic SIJ pain at nine sites in four European countries were randomly assigned to and underwent either minimally invasive SIJF using triangular titanium implants (N = 52) or CM (N = 51). CM was performed according to the European guidelines for the diagnosis and management of pelvic girdle pain and consisted of optimization of medical therapy, individualized physical therapy (PT) and adequate information and reassurance as part of a multifactorial treatment. The primary outcome was the difference in change in self-rated low back pain (LBP) at 6 months. Additional endpoints included quality of life using EQ-5D-3L, disability using Oswestry Disability Index (ODI), SIJ function using active straight leg raise (ASLR) test and adverse events. NCT01741025.
Results: At 6 months, mean LBP improved by 43.3 points in the SIJF group and 5.7 points in the CM group (difference of 38.1 points, p<0.0001). Mean ODI improved by 26 points in the SIJF group and 6 points in the CM group (p<0.0001). ASLR, EQ-5D-3L, walking distance and satisfaction were statistically superior in the SIJF group. The frequency of adverse events did not differ between groups. One case of postoperative nerve impingement occurred in the surgical group.
Conclusions: In patients with chronic SIJ pain, minimally invasive SIJF using triangular titanium implants was safe and more effective than CM in relieving pain, reducing disability, improving patient function and quality of life.
KEYWORDS: Sacroiliac joint dysfunction - Pelvic girdle pain - Sacroiliac joint fusion - Titanium sacroiliac implant - Randomized controlled trial – Conservative management - iFuse Implant System
Author Information
Bengt Sturesson – Department of Orthopedics, Aleris, Ängelholm Hospital, Ängelholm, Sweden.
Djaya Kools – Department of Neurosurgery, Onze-Lieve-Vrouw Hospital Aalst, Aalst, Belgium.
Robert Pflugmacher – Department of Orthopedics and Traumatology, University Hospital Bonn, Bonn, Germany.
Alessandro Gasbarrini – Instituto Ortopedico Rizzoli di Bologna, Bologna, Italy.
Domenico Prestamburgo – Department of Orthopedics and Traumatology, ASST Ovest Milanese Ospedale di Legnano, Legnano, Italy.
Julius Dengler – Department of Neurosurgery, Charité - Universitaetsmedizin Berlin, Campus Virchow Klinikum, Augustenburger Platz 1, 13353, Berlin, Germany.
Disclosures: Bengt Sturesson, Julius Dengler, Djaya Kools, Robert Pflugmacher, Domenico Prestamburgo and Alessandro Gasbarrini are investigators in SI-BONE clinical trials. Bengt Sturesson, Djaya Kools and Robert Pflugmacher are paid consultants to SI-BONE. The trial reported herein was funded by SI-BONE.