24-Month Outcomes of Indirect Decompression Using a Minimally Invasive Interspinous Fixation Device versus Standard Open Direct Decompression for Lumbar Spinal Stenosis: A Prospective Comparison

Ganesan Baranidharan,1,2 Beatrice Bretherton,1,3 Richard G Feltbower,4 Jake Timothy,5 Almas Latif Khan,6,7 Ashok Subramanian,8 Mushtaq Ahmed,9 Tracey A Crowther,1,10 Helen Radford,10,11 Harun Gupta,12 Muthusamy Chandramohan,13 Douglas P Beall,14 Timothy R Deer,15 Thomas Hedman16 1Pain Management Department, Leeds Teaching Hospitals NHS Trust, Leeds, UK; 2School of Medicine, University of Leeds, Leeds, UK; 3School of Biomedical Sciences, Faculty of Biological Sciences, University of Leeds, Leeds, UK; 4Leeds Institute for Data Analytics, School of Medicine, University of Leeds, Leeds, UK; 5Department of Neuroscience, Leeds Teaching Hospitals NHS Trust, Leeds, UK; 6Department of Spine Surgery, Leeds Teaching Hospitals NHS Trust, Leeds, UK; 7Institute of Medical and Biological Engineering, University of Leeds, Leeds, UK; 8Somerset Spinal Surgery Service, Musgrove Park Hospital, Taunton, UK; 9Department of Trauma and Orthopaedic Surgery, Dudley Group NHS Foundation Trust, Dudley, UK; 10Research & Innovation, Leeds Teaching Hospitals NHS Trust, Leeds, UK; 11Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK; 12Department of Radiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK; 13Radiology Department, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK; 14Comprehensive Specialty Care, Edmond, OK, USA; 15The Spine and Nerve Center of the Virginias, Charleston, WV, USA; 16Department of Biomedical Engineering, University of Kentucky, Lexington, KY, USACorrespondence: Ganesan Baranidharan, Pain Management Department, Leeds Teaching Hospitals NHS Trust, Leeds, UK, Email g.baranidharan@nhs.netPurpose: An early-stage, multi-centre, prospective, randomised control trial with five-year follow-up was approved by Health Research Authority to compare the efficacy of a minimally invasive, laterally implanted interspinous fixation device (IFD) to open direct surgical decompression in treating lumbar spinal stenosis (LSS). Two-year results