Implant procedure helps patients with sacroiliac joint pain
A minimally invasive implant procedure is highly effective in reducing pain and disability for patients with sacroiliac joint (SIJ) dysfunction, reports a clinical trial published in the November issue of Neurosurgery. The first randomised controlled trial to directly compare the results of surgical and non-surgical treatment for SIJ dysfunction showed better outcomes in patients undergoing minimally invasive SIJ fusion, compared with non-surgical management.
The study, overseen by Daniel Cher of SI-BONE, included 148 patients with low back pain caused by confirmed SIJ dysfunction, treated at 19 US spine surgery clinics. SIJ disruption or osteoarthritis is estimated to cause 15–23 per cent of cases of chronic low back pain. Trial subjects had severe SIJ pain, with an average pain score of 82 on a zero-to-100-point scale. Average pain duration was longer than six years, and about two-thirds of subjects were taking opioid medications. Many had previously received non-surgical SIJ treatment, and/or had a history of prior spinal surgery.
Two-thirds of subjects were randomly assigned to undergo minimally invasive SIJ fusion, where triangular titanium implants were placed through a small incision to stabilise and fuse the SIJ. Procedures were unilateral in most cases, but some subjects underwent bilateral treatment. The remaining subjects received non-surgical treatments, such as physical therapy, steroid injections and/or radiofrequency ablation of sacral nerve root lateral branches. Pain and other outcomes were compared at baseline and at one, three, six and 12 months. At six months, subjects in the non-surgical group had the option to ‘cross over’ to the implant procedure.
Based on reduction in pain and absence of complications at six months, treatment was rated successful in 81 per cent of subjects assigned to the SIJ implant procedure, compared with 26 per cent with non-surgical treatment. Average pain score decreased to 30 in the surgical group versus 72 in the non-surgical group; 73 per cent of subjects undergoing the implant procedure had ‘clinically significant’ reduction in disability scores, compared with just 14 per cent in the non-surgical group. After one year, subjects assigned to SIJ fusion still had significant reductions in pain and disability, as well as improved quality of life. Thirty-five subjects from the non-surgical group opted to undergo the implant procedure, with similarly good results. There were only a few complications related to the SIJ implant procedure.
The authors noted some important limitations of the trial, including a lack of long-term outcomes in the non-surgical group due to the high crossover rate. They plan further analyses, including two-year follow-up CT scans and a cost-effectiveness comparison of SIJ fusion versus non-surgical treatment.