Six-month outcomes from a randomized controlled trial of minimally invasive SI joint fusion with triangular titanium implants vs conservative management

Bengt Sturesson, Djaya Kools, Robert Pflugmacher, Alessandro Gasbarrini, Domenico Prestamburgo, Julius Dengler

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)708-719
Number of pages12
JournalEuropean Spine Journal
Volume26
Issue number3
DOIs
Publication statusPublished - Jan 2017

Keywords

  • Conservative management
  • iFuse Implant System
  • Pelvic girdle pain
  • Randomized controlled trial
  • Sacroiliac joint dysfunction
  • Sacroiliac joint fusion
  • Titanium sacroiliac implant

ASJC Scopus subject areas

  • Surgery
  • Orthopedics and Sports Medicine

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