One-year results from the IMIA (Ifuse Implant System Minimally Invasive Arthrodesis) randomised controlled trial have shown better pain and disability improvements for SI-Bone’s Ifuse system than conservative care.
IMIA is a Level 1 clinical trial conducted at nine hospitals in four countries in Europe. It assessed the safety and effectiveness of sacroiliac joint fusion with the Ifuse implant compared to conservative management in patients with chronic sacroiliac joint dysfunction.
The study was published in Pain Physician.
Results showed that for patients with chronic low back pain (LBP) due to certain types of sacroiliac joint dysfunction, minimally invasive sacroiliac joint fusion with the Ifuse implant was safe and more effective than conservative management in relieving pain, reducing disability, and improving patient function and quality of life.
The study included 109 subjects enrolled between June 2013 and May 2015. Follow-up for this publication extends through October 2016. Mean age was 48.1 years.
Seventy-five subjects (72.8%) were women, and mean sacroiliac joint pain duration was 4.7 years.
Most participants (72.8%) had undergone prior sacroiliac joint steroid injections, a minority (16.5%) had had prior radiofrequency ablation and about one third (35.9%) had undergone prior lumbar fusion.
Patients in the surgical arm of the study were treated with the Ifuse implant. Over 25,000 patients have been treated with the device to date.
At one year, mean low back pain improved by 41.6 (0–100 Visual Analogue Scale) in the sacroiliac joint fusion group compared to 14 points in the conservative management group (Figure 1). The mean 25-point Oswestry Disability Index (ODI) improvement in the fusion group compared to 8.7 points in the conservative management group (Figure 2).
Mean improvements in leg pain and EQ-5D-3L were large after sacroiliac joint fusion and superior to those after conservative management.
Conservative management subjects were allowed to cross over to sacroiliac joint fusion after six months.
Results reveal that subjects who crossed over to surgical treatment had no pre-crossover improvement in pain and ODI scores. After crossover, improvements in most measures were as large as those patients originally assigned to SI joint fusion.
“It has been most gratifying to be a part of this important trial to help identify the value and benefits of the use of the iFuse Implant for SI joint patients who no longer benefit from conservative therapies,” said Bengt Sturesson (Ängelholm Hospital, Ängelholm, Sweden), one of the study authors. “The one-year results from IMIA clearly show consistent outcomes with the previously published US randomised controlled trial, INSITE, thus further validating the applicability of the Ifuse Implant to patients across a broad spectrum of clinical practitioners.”