The International Society for the Advancement of Spine Surgery released two new statements: one focused on bone graft substitutes and the other examining vertebral augmentation. The bone graft substitute statement outlines historical use and U.S. regulatory pathways for bone grafts, including nonstructural allografts, demineralized bone grafts, cellular-based allografts, synthetic bone grafts, autologous cellular grafts and Class III drug-device combination products. “Bone grafting is an essential part of spinal surgery and ever-evolving science,” concluded the recommendation authors. “With each new advance, one needs to understand the characteristics of material, its mechanism of action, the regulatory pathway by which it came to market and the preclinical and human clinical evidence available on which to base a clinical use decision.” The authors found: Nonstructural cancellous allograft […]
Read the Spring 2019 issue of Vertebral Columns. In this issue: Reevaluating indications for cervical TDA, decreasing hospital stays, MIS options for pelvic fixation, maximizing lordosis, and a review of the literature surrounding PROMIS!
Vertebral Augmentation: Coverage Indications, Limitations, and/or Medical Necessity OLIVIER CLERK-LAMALICE,1 DOUGLAS P. BEALL,2 KEVIN ONG,3 MORGAN P. LORIO4 1Western Canada Pain Institute, Edmonton, Alberta, Canada, 2Clinical Radiology of Oklahoma, Edmond, Oklahoma,3Exponent, Inc., Philadelphia, Pennsylvania, 4Hughston Clinic Orthopaedics—Centennial, Nashville, Tennessee ABSTRACT The ISASS Policy Statement on vertebral augmentation has the objectives to provide a background and an update with the latest clinical evidence for the international spine community. A SpineLine Panel Review (2010) appropriately recommended an exploration of ‘‘the seeming disconnect between the conclusions of . . . two [Level I] PRCT’s and previous experience and data’’ regarding vertebral augmentation. ISASS responded by supporting a comprehensive meta-analysis to help frame a cogent historical analysis of vertebral augmentation. This ISASS Policy 2018 […]
Washington State Health Authority Holds Public Forum on Draft Policy on Minimally Invasive Sacroiliac Joint Fusion
On January 18, 2019, the state of Washington’s State Health Authority Health Technology Assessment committee held an open public forum for stakeholders to provide feedback and input on the December 2018 draft report on Minimally Invasive Sacroiliac Joint Fusion (SIJ). Multiple stakeholders provided input, including ISASS member Dr. David Polly, who presented slides and clinical feedback to the assessment committee. The committee will take public comments into account and issue a final report in the coming weeks. Read the December 2018 draft report here: Read ISASS comment letter to November 2018 draft report here