A multicenter retrospective analysis of the long-term efficacy and safety of a novel posterior sacroiliac fusion device

Abstract

Background: Sacroiliac joint (SIJ) pathology is a cause of low back pain that may be difficult to diagnose and challenging to treat. Open and minimally invasive (MI) lateral approach fusions have been used to treat sacroiliitis over the past two decades. A novel MI posterior approach SIJ fusion technique utilizes a posteriorly placed transfixing device with single point S1/S2 level or mid-segment SIJ fixation (LinQ procedure). Current efficacy and safety data for this novel procedure are lacking. Objective: To review multicenter retrospective 12 months or greater outcomes data in patients receiving the LinQ procedure, with sub-analysis of patients with prior lumbar fusions. Methods: Patients with sacroiliitis refractory to conservative care with short-term benefit from diagnostic local anesthetic SIJ injections receiving MI posterior approach SIJ fusion with allograft were included from different centers including both academic and private practice. Numeric rating scale (NRS) scores at baseline (pre-procedural) and most recent follow-up were reviewed across three institutions. Results: Of 110 patients who received MI SIJ fusion, 50 patients had sufficient data for evaluation of outcomes at least 12 months post-implant. The average time out from implant at follow-up was 612.2 days for all unique patients. The average NRS was 6.98 pre-fusion and 3.06 at last follow-up. Twenty-four patients had prior lumbar surgery of which 17 had prior lumbar fusions. Average NRS for this subset was 6.85 at baseline and 2.86 at last follow-up with an average follow-up of 613.2 days out from implant. No major adverse events or complications were associated with any of the 50 implants. Conclusion: Real-world evidence suggests that MI posterior SIJ fusion with the LinQ procedure is a viable approach for medically refractory sacroiliitis management with long-term efficacy and safety. Further prospective studies are needed to fully evaluate this technique.