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.

Research suggests that sacroiliac joint (SIJ) dysfunction is responsible for 15% to 30% of reported low back pain cases. Recently, there has been an increasing interest in SIJ fusion using minimally invasive surgery (MIS) due to safety. Initially, devices designed for MIS were intended for lateral approaches. A minimally invasive sacroiliac fusion implant for use with a posterior approach has been developed and is regulated for clinical use under the regulatory framework required for human cells, tissues, or cellular or tissue-based products (HCT/Ps). A multi-center, prospective, single-arm study was launched after initial studies provided preliminary data to support safety, efficacy, and durability of this minimally invasive sacroiliac posterior fusion LinQ allograft implant (NCT04423120). Preliminary results were reported previously. Final results for the full participant cohort are presented here. One-hundred and fifty-nine (159) participants were enrolled across 16 investigational sites in the US between January 2020 and March 2022. One-hundred and twenty-two (122) participants were implanted. At the 1-month follow-up, 82 participants satisfied all criteria for the composite responder endpoint, representing 73.2% of the study cohort. These results stayed consistent across the remaining study timepoints with 66.0%, 74.4%, and 73.5% of participants classified as responders at the 3-, 6- and 12-month follow-up visits, respectively. VAS scores were significantly reduced (p < 0.0001) and ODI scores were significantly improved (p < 0.0001). All domains of the PROMIS-29 were also significantly improved (all p's <0.0001). Only one procedure-related serious AE was reported in the study. These results suggest that the posterior approach LinQ Implant System is a safe and effective treatment for sacroiliac joint dysfunction at 12 months, with results that are favorable compared to outcomes reported for an FDA-cleared lateral approach.

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© 2024 Calodney et al.

Déclaration de conflit d'intérêts

Dr Calodney reports being a consultant for Medtronic, Companion Spine, PainTeq, and Vertos, was a speaker for Relievant, and got research support from Medtronic, Nevro, Stryker, Boston Scientific, Spine Biopharma, Biorestorative, Vivex, Saluda, DiscGenics, outside the submitted work. Dr. Azeem serves on the advisory board for PainTEQ, Vertos, Spinal Simplicity, Vivex, Ethos labs and is a consultant/speaker for Abbott, Medtronic, Boston Scientific; he has received research support from PainTEQ, Vivex, Abbott, Medtronic, Ethos Labs. Dr. Buchanan serves as a consultant and Principal Investigator for Abbott and PainTEQ. Dr. Lubenow serves as a consultant for Abbott, Medtronic, Boston Scientific, PainTEQ, and Nevro and has received research support from Abbott and PainTEQ. Dr. Li serves as a consultant for Abbott, Avanos, Averitas Pharm, Biotronik, Boston Scientific, Nalu Medical, Nevro, PainTEQ, Saluda Medical, SPR Therapeutics, Vertos Medical, and is on the Speaker’s Bureau for Scilex Pharm, and has Stock Options in Nalu Medical. He has received research support from Avanos, Biotronik, Boston Scientific, SGX Medical, Nalu Medical, PainTEQ, Saluda Medical, and SPR Therapeutics. Dr. Deer serves as a consultant for Abbott, Medtronic, Cornorloc, PainTEQ, Spinal Simplicity, SPR, Saluda; he has received research support from Abbott, Vertiflex (BSI), PainTEQ, Vertos, and Saluda. Dr. Josephson serves as a consultant for PainTEQ, Boston Scientific, NALU, Bioness, Aurora, and Medtronic and has received research support from Aurora, and PainTEQ. Dr. Vu serves as a consultant for PainTEQ and Saluda and receives research support from Abbott, Flowonix, Saluda, Aurora, PainTEQ, Ethos, Muse, Boston Scientific, SPR Therapeutics, Mainstay, Vertos, AIS, and Thermaquil. Dr. Girardi serves as a consultant for Abbott and PainTEQ. Dr. Kim serves as a consultant for Boston Scientific, Vertos, PainTEQ, and Abbott and has received research support from Abbott and PainTEQ. Dr. Vogel previously served as a consultant for PainTEQ. Dr. Skaribas previously served as a consultant for PainTEQ. Dr. Antony serves as a consultant/speaker for Boston Scientific, Abbott, Nalu, PainTEQ, Saluda, Vertos; he has received research support from ViaDISC, Abbott, Boston scientific, PainTEQ, Saluda, and SPR. Dr. Bovinet serves as a consultant for PainTEQ, Boston Scientific, Vertos, Nevro, and Spinal Simplicity and has received research support from PainTEQ, Nevro, Boston Scientific. Dr. Jassal has received research support from AIS, Flowonix, Boston Scientific, PainTEQ, and Vertos. The authors report no other conflicts of interest in this work.