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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

Aims: To assess HbA1c values and hospitalization rates before, during and after continuous subcutaneous insulin infusion (CSII) therapy. Methods: Demographic and hospitalization data were extracted from 161 individuals with Type 1 diabetes who received continuous subcutaneous insulin infusion (CSII) therapy between 2002 and 2013 at the Leeds Children and Young People's Diabetes Service for those aged < 20 years. The median (range) age at CSII start was 11.9 (1.1–17.6) years. The median (range) follow‐up time was 2.3 (0–8.1) years. Random intercept models were used to compare HbA1c values before and during CSII initiation (and after CSII for those who discontinued it). Hospitalization rates were calculated for diabetic ketoacidosis and severe hypoglycaemia. Results: The mean HbA1c concentration decreased by 7 mmol/mol [95% CI 6–8; 0.6% (95% CI 0.5–0.7%)]. For the discontinued group (n=30), mean HbA1c decreased by 5 mmol/mol [95% CI 2–8; 0.4% (95% CI 0.2–0.7%)]. HbA1c returned to pre‐CSII start levels at the end of this therapy. Diabetic ketoacidosis admissions increased threefold during CSII compared with before CSII start [2.2 per 100 person‐years (95% CI 1.3 to 3.6) vs 7.4 per 100 person‐years (95% CI 5.1 to 10.8)] and was highest during the first year of CSII. No difference in severe hypoglycaemia incidence rate was found during CSII compared with the pre‐CSII period. Conclusions: Despite significant reductions in HbA1c levels for individuals treated with CSII, improvements are needed to reduce diabetic ketoacidosis hospitalizations for those new to the therapy. What's new?: Multi‐level modelling found that HbA1c values decreased with continuous subcutaneous insulin infusion (CSII) therapy, including in individuals who eventually discontinued CSII; however, these individuals returned to pre‐CSII start HbA1c levels after returning to multiple daily injections.HbA1c levels improved for up to 4 years of CSII therapy. For boys/men, this improvement was maintained for 6 years, compared with only 3 years in girls/women. Girls/women were also more likely to discontinue CSII therapy.Hospitalization rates increased for diabetic ketoacidosis in the first year of CSII therapy, but was no different from pre‐CSII rates thereafter. [ABSTRACT FROM AUTHOR]