An inception cohort study of patients in a military clinic treated for lower back pain with lumbar fusion and SIGNAFUSE? with a systematic review of the literature

Author Info

Scott Seaman Adam J. Bevevino Joshua P. Herzog R. Grant Steen

Corresponding Author

R. Grant Steen
Department of Orthopaedic Surgery, Louisiana State University Medical Center, New Orleans, LA, Medical Affairs, Bioventus LLC, 4721 Emperor Blvd., Suite 100, Durham, NC 27703

A B S T R A C T

Background: Use of synthetic bone graft substitutes for spinal fusion has increased sharply over the past 20 years. SIGNAFUSE® is one such synthetic graft material that provides an osteostimulatory effect for spinal fusion. Because clinical trials are not required for commercialization of synthetic bone graft substitutes in the United States, fusion rates attained using SIGNAFUSE for lumbar fusion are not well documented. The goal of the current study is to determine the rate of spinal fusion in a military clinic following lumbar fusion surgery augmented with SIGNAFUSE. Methods: We report a retrospective chart review of 8 patients who received lumbar spinal fusion surgery augmented with SIGNAFUSE. All patients were assessed by computed tomographic (CT) imaging at least 1-year post-surgery to determine whether bony fusion had occurred. We also systematically reviewed literature sources that report fusion rate following spinal fusion surgery, for broader context. Results: An average of 1.6 spinal levels were treated with SIGNAFUSE-loaded interbody cages. All patients had stabilization hardware via pedicle screws or integrated cage fixation. Seven of 8 patients successfully fused, for an overall fusion rate of 87.5% (95% confidence interval: 47.4% to 99.7%). Systematic review of 26 recent publications that included 1,126 patients treated with synthetic bone graft showed that the overall fusion rate in the literature is 84.4%. Conclusions: Fusion was achieved in 87.5% of patients treated with SIGNAFUSE. This is comparable to the fusion rate in a systematic review of 1,126 patients treated with synthetic bone graft materials.

Article Info

Article Type

Case Report

Publication history

Received: Fri 30, Nov 2018
Accepted: Tue 11, Dec 2018
Published: Mon 31, Dec 2018

Copyright

© 2023 R. Grant Steen. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Hosting by Science Repository.
DOI: 10.31487/j.SCR.2018.03.025