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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 are presented.Patients and Methods: Forty-eight participants were randomly assigned to IFD or decompression. Primary study endpoints included changes from baseline at 8-weeks, 6, 12 and 24-months follow-ups for leg pain (visual analogue scale, VAS), back pain (VAS), disability (Oswestry Disability Index, ODI), LSS physical function (Zurich Claudication Questionnaire), distance walked in five minutes and number of repetitions of sitting-to-standing in one minute. Secondary study endpoints included patient and clinician global impression of change, adverse events, reoperations, operating parameters, and fusion rate.Results: Both treatment groups demonstrated statistically significant improvements in mean leg pain, back pain, ODI disability, LSS physical function, walking distance and sitting-to-standing repetitions compared to baseline over 24 months. Mean reduction of ODI from baseline levels was between 35% and 56% for IFD (p< 0.002), and 49% to 55% for decompression (p< 0.001) for all follow-up time points. Mean reduction of IFD group leg pain was between 57% and 78% for all time points (p< 0.001), with 72% to 94% of participants having at least 30% reduction of leg pain from 8-weeks through 24-months. Walking distance for the IFD group increased from 66% to 94% and sitting-to-standing repetitions increased from 44% to 64% for all follow-up time points. Blood loss was 88% less in the IFD group (p=0.024) and operating time parameters strongly favoured IFD compared to decompression (p< 0.001). An 89% fusion rate was assessed in a subset of IFD participants. There were no intraoperative device issues or re-operations in the IFD group, and only one healed and non-symptomatic spinous process fracture observed within 24 months.Conclusion: Despite a low number of participants in the IFD group, the study demonstrated successful two-year safety and clinical outcomes for the IFD with significant operation-related advantages compared to surgical decompression.Keywords: lumbar spinal stenosis, surgical decompression, posterior lateral arthrodesis, patient reported outcomes, minimally invasive spine, interspinous fixation device

Introduction: Both knotted all suture anchors and metal anchors are used for arthroscopic Bankart repair. We retrospectively evaluated and compared clinical and functional outcomes after arthroscopic Bankart repair using the knotted all-suture anchors and knotted metal anchors. Materials and methods: In a retrospective cohort analysis, patients who underwent arthroscopic Bankart repair without any concomitant additional lesion repair using either all-suture anchors or metal anchors, between January 2015 and May 2018 were identified. Their pre- and post-operative functional and clinical outcomes were compared using Rowe and WOSI scores. The recurrence rate in the two groups was also compared. Results: A total of 41 patients in all suture anchors group and 47 in the metal anchors group were identified as per inclusion and exclusion criteria. The demographic profile of both groups was comparable. There was no significant difference in clinical and functional outcome between the two suture anchor groups as per Rowe (pre-operative 40.13+6.51 vs 38.09+6.24 and post-operative 2 years 93.28+7.09 vs 92.55+9.2) and WOSI (pre-operative 943.05+216.64 vs 977.55+165.46 and post-operative 2 years 278.21+227.56 vs 270.94+186.25) scores. There was a significant improvement in both the groups between pre-operative and post-operative ROWE and WOSI scores at 6 months and 2 years follow-up as compared to pre-operative scores (p