The following is a summary of “Safety, Efficacy, and Durability of Outcomes: Results from SECURE: A Single Arm, Multicenter, Prospective, Clinical Study on a Minimally Invasive Posterior Sacroiliac Fusion Allograft Implant,” published in the March 2024 issue of Pain by Calodney et al.
Researchers conducted a retrospective study evaluating the effectiveness of a minimally invasive surgery (MIS), sacroiliac joint (SIJ) fusion implant regulated as human cells, tissues, or cellular or tissue-based product (HCT/P) for treating SIJ dysfunction.
They initiated a multicenter, prospective, single-arm study following preliminary data supporting the safety, efficacy, and durability of the MIS posterior fusion LinQ allograft implant. Previous reports covered preliminary findings. Here, they present the final results for the entire participant cohort.
The results showed 159 participants at 16 investigational sites in the US (January 2020 and March 2022), and 122 participants received implants. At the 1-month follow-up, 82 participants met all criteria for the composite responder endpoint, accounting for 73.2% of the study cohort. Similar percentages of responders were observed at 3, 6, and 12 months of follow-up, with 66.0%, 74.4%, and 73.5%, respectively. Significant reductions were seen in VAS scores (P<0.0001) and improvements in ODI scores (P<0.0001). All domains of PROMIS-29 showed substantial improvements (all P’s <0.0001). Only one procedure-related serious AE was reported.
Investigators concluded that LinQ Implant System’s posterior approach was safe and effective for treating SIJ dysfunction at 12 months, with outcomes favorable to those reported for an FDA-cleared lateral approach.
