Posterior Lateral Arthrodesis as a Treatment Option for Lumbar Spinal Stenosis: Safety and Early Clinical Outcomes

Abstract

Introduction

Lumbar spinal stenosis (LSS) is a common condition caused by degenerative changes in the lumbar spine with age. LSS is caused by a variety of factors, including degenerative spondylosis and spondylolisthesis. People suffering with LSS experience neurogenic claudication, which causes severe physical limitations, discomfort, and a decrease in quality of life. Less invasive procedures are now being researched to improve the prognosis, success rate, and safety of LSS treatments. Posterior lateral spinal arthrodesis (PLSA) is a new surgical treatment for LSS. This study looks at the procedural and patient safety of PLSA.

Materials and methods

This study is a multicenter retrospective analysis of the safety of PLSA who met the clinical indications for PLSA and underwent the procedure at eight interventional spine practices. Data was collected on demographical information, pre-procedural numeric rating scale score (NRS), post-procedural NRS, and complication reporting. Patients who were included had LSS with or without spondylolisthesis and had failed conservative treatments. A descriptive statistical analysis was performed to report the outcomes. Results were reported as mean and standard deviations for continuous outcomes, and frequency (%) for categorical outcomes.

Results

This retrospective analysis involved 191 patients and 202 PLSA implants. The majority of patients were male Caucasians with a mean age of 69.2 years and a BMI of 31.1. A large majority of implants were placed at the L4-5 level, and the average pre-procedural NRS was 6.3 while the average post-procedural NRS was 3.1, indicating a 50.8% reduction in pain (p < 0.0001). Two patients reported complications, but they were unrelated to the device or surgical procedure; no infections, device malfunctions, or migrations were reported in the patient cohort.

Conclusion

Preliminary results with PLSA implants indicate that it is a safe treatment option for patients with moderate LSS who do not respond to conservative management.

Keywords:

• lumbar spinal stenosis
• spondylolisthesis
• interspinous fusion
• Minuteman
• spinal simplicity
• posterior lateral spinal arthrodesis

Ethics Statement

This study was approved by the internal review committee at Thomas Health/Saint Francis Hospital, Charleston, WV. This committee waived the need to obtain consent for the collection, analysis and publication of the retrospectively obtained and deidentified data for this study.

Disclosure

Ashley Bailey-Classen MD: Speaker’s Bureau for Medtronic. Consultant for Nevro and Biotronik. Medical Advisory Board for Spinal Simplicity.

Usman Latif MD: Consultant, Speaker, and Advisory Board for Spinal Simplicity. Consultant for Omnia Medical. Consultant, Speaker, and Advisory Board for Nevro. Consultant and Speaker for Nalu Medical. Consultant and Speaker for Vertos. Consultant for Hydrocision. Consultant and Advisory Board for InFormed Consent. Investigator and Funded Research for Mainstay Medical.

Nomen Azeem MD: Related: Consultant to Spinal Simplicity. Unrelated: Consultant to Abbott, Medtronic, Biotronik, Vertos, Vivex, Ethos Labs, Painteq. Funded Research: Painteq, Vivex, Ethos Labs Minor equity: Spinal Simplicity.

Douglas Beall MD: Consultant: Medtronic, Spineology, Merit Medical, Johnson & Johnson, IZI, Techlamed, Peterson Enterprises, Medical Metrics, Avanos, Boston Scientific, Sollis Pharmaceuticals, Simplify Medical, Stryker, Lenoss Medical, Spine BioPharma, Piramal, ReGelTec, Nanofuse, Spinal Simplicity, Pain Theory, Spark Biomedical, Micron Medical Corp, Bronx Medical, Smart Soft, Tissue Tech, RayShield, Stayble, Thermaquil, Vivex, Stratus Medical, Genesys, Abbott, Eliquence, SetBone Medical, Amber Implants, Cerapedics, Neurovasis, Varian Medical Systems, Companion Spine, DiscGenics, Discure, SpinaFX, PainTEQ; grants from Medtronic, Medical Metrics, Avanos, Relievant, Boston Scientific, Stryker, Sollis Pharmaceuticals, Simplify Medical, Lenoss Medical, Spine BioPharma, Eliem Therapeutics, Smart Soft, Tissue Tech, Vivex, Stratus Medical, Restorative Therapies, Kolon TissueGene, Companion Spine, DiscGenics; personal fees from Medtronic, ReGelTec, Nanofuse, Talosix, Spinal Simplicity, Pain Theory, Spark Biomedical, Smart Soft, Tissue Tech, Bronx Medical, Thermaquil, Vivex, Genesys, SetBone Medical, Amber Implants, Cerapedics, SpinaFX; non-financial support from Thieme, Springer, Humana.

Chad Stephens: Teaching consultant and medical advisory board from Spinal Simplicity, outside the submitted work.

Larry Khoo MD: Related: Spinal simplicity: speaker, consultant, and minor shareholder. Unrelated: Consultant: Aesculap Spine, Globus Medical, Nuvasive. Spine, SeaSpine, Zimmer Spine, Choice Spine, Camber Spine, Burst Biologics, Augmedics, Spineguard, Amplify Spine, Medtronic Midas Rex, Carevature Spine.

Timothy Deer: Related: Consultant to Spinal Simplicity Unrelated: Consultant to SPR, Nalu, Mainstay, Consultant to Abbott, Saluda, Painteq, Spinal Simplicity; Funded Research: Boston Scientific, Abbott, SPR, Mainstay Minor equity: Ethos, Spinthera, Cornorloc, Painteq, Spinal Simplicity, Saluda.

The authors report no other conflicts of interest in this work.