1. 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
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Calodney A, Azeem N, Buchanan P, Skaribas I, Antony A, Kim C, Girardi G, Vu C, Bovinet C, Vogel R, Li S, Jassal N, Josephson Y, Lubenow T, Lam CM, and Deer TR
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sacroiliac joint disease ,sacroiliac fusion ,single point posterior fusion ,back pain ,minimally invasive spine surgery ,sacroiliitis ,Medicine (General) ,R5-920 - Abstract
Aaron Calodney,1 Nomen Azeem,2 Patrick Buchanan,3 Ioannis Skaribas,4 Ajay Antony,5 Christopher Kim,6 George Girardi,7 Chau Vu,8 Christopher Bovinet,9 Rainer Vogel,10 Sean Li,11 Navdeep Jassal,12 Youssef Josephson,13 Timothy Lubenow,14 Christopher M Lam,15 Timothy R Deer6 1Precision Spine Care, Tyler, TX, USA; 2Florida Spine and Pain Specialists, Tampa, FL, USA; 3Spanish Hills Interventional Pain Specialists, Camarillo, CA, USA; 4Expert Pain P.A, Houston, TX, USA; 5The Orthopaedic Institute, Gainesville, FL, USA; 6The Spine and Nerve Center, Charleston, WV, USA; 7Front Range Pain Medicine, Fort Collins, CO, USA; 8Evolve Restoration Center, Santa Rosa, CA, USA; 9The Spine Center of Southeast Georgia, Brunswick, GA, USA; 10Comprehensive and Interventional Pain Management, Henderson, NV, USA; 11Premier Pain Centers, Shrewsbury, NJ, USA; 12Excel Pain and Spine, Lakeland, FL, USA; 13The Pain Management Center, Voorhees Township, NJ, USA; 14Rush University Medical Center, Chicago, IL, USA; 15University of Kansas Medical Center, Kansas City, KS, USACorrespondence: Aaron Calodney, Precision Spine Care, Tyler, TX, USA, Email aaroncalodney@me.comIntroduction: 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).Methods: 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.Results: 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.Conclusion: 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.Keywords: sacroiliac joint disease, sacroiliac fusion, single point posterior fusion, back pain, minimally invasive spine surgery, sacroiliitis
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- 2024