Clinical Data
6-months results, double-blind RCT, iFuse vs. sham (Randers - eClinicalMedicine 2024)
The effect of minimally invasive sacroiliac joint fusion compared to sham operation: a double-blind randomized placebo-controlled trial
Randers EM, Gerdhem P, Stuge B, Diarbakerli E, Nordsletten L, Röhrl SM, Kibsgård TJ.
eClinicalMedicine. 2024 Feb 1;68:102438.
DOI: 10.1016/j.eclinm.2024.102438. PMID: 38328752; PMCID: PMC10847054.
ABSTRACT
Background: Minimally invasive fusion of the sacroiliac joint as treatment for low back pain may reduce pain and improve function compared to non-operative treatment, although clear evidence is lacking. The aim of this trial was to evaluate the effect of minimally invasive sacroiliac joint fusion compared to sham surgery on sacroiliac joint pain reduction.
Methods: In this double-blind randomized sham surgery-controlled trial patients with clinical diagnosis of sacroiliac joint pain confirmed with sacroiliac joint injection were included at two university hospitals in Sweden and Norway. Patients were randomized by the operating surgeon at each site to minimally invasive sacroiliac joint fusion or sham surgery. The primary endpoint was group difference in sacroiliac joint pain on the operated side at six months postoperatively, measured by the Numeric Rating Scale (0-10). Un-blinding and primary analysis were performed when all patients had completed six months follow-up. The trial is closed for new participants and was registered at clinicaltrials.gov: NCT03507049.
Findings: Between September 1st, 2018 and October 22nd, 2021, 63 patients were randomized, 32 to the surgical group, 31 to the sham group. Mean age was 45 years (range 26-63) and 59 of 63 (94%) patients were female. The mean reduction in the operated sacroiliac joint from baseline to six months postoperative was 2.6 Numeric Rating Scale points in the surgical group and 1.7 points in the sham group (mean between groups difference -1.0 points; 95% CI, -2.2 to 0.3; p = 0.13).
Interpretation: This double-blind randomized controlled trial could not prove that minimally invasive fusion of the sacroiliac joint was superior to sham surgery at six months postoperative.
Funding: Sophies Minde Ortopedi supported a clinical research position for Engelke Marie Randers. Region Stockholm supported the cost for the Swedish ethical application and a clinical research appointment for Paul Gerdhem.
Keywords: Orthopedic surgery; Placebo; Sacroiliac joint fusion; Sacroiliac joint pain; Sham surgery.
Author Information
- Randers EM, Stuge B, Kibsgård TJ, Nordsletten L - Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway; Institute of Medicine, University of Oslo, Oslo, Norway.
- Gerdhem P - Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden; Department of Surgical Sciences, Uppsala University, Sweden; Department of Orthopaedics and Hand Surgery, Uppsala University Hospital, Sweden.
- Diarbakerli E - Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden; Department of Reconstructive Orthopedics, Karolinska University Hospital, Stockholm, Sweden.