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Abstract Background One in three women and one in five men over the age of 50 will experience an osteoporotic fracture. Vertebral fractures can be very painful, affect patients’ daily function, and in severe cases require hospitalization. Traditionally, fracture pain is treated conservatively with analgesics, and bracing. Vertebral augmentation, also known as vertebroplasty, has been used during the last three decades as a minimally invasive treatment option for vertebral compression fractures, but the evidence base for its efficacy is weak. We describe a double-blind randomized sham-controlled clinical trial to assess the impact of vertebroplasty on self-reported clinical outcomes in patients with painful osteoporotic vertebral compression fractures and vertebral oedema. Methods Two hundred and forty patients with painful osteoporotic vertebral fractures and MRI verified oedema will be randomized in a prospective, double-blind, single-center, clinical trial to either vertebroplasty or a sham procedure, with the possibility of crossover 12 weeks after randomization and operation. The primary outcome will be difference in self-reported pain 12 weeks after treatment between the vertebroplasty and sham group. Secondary outcomes will be patient-reported disability, health-related quality of life, societal costs of treatment and complications. Analysis will be based on intention-to-treat. Repeated measures ANCOVA with baseline ODI, Numerical Pain Rating Scale, EQ-5D-5 L, and number of levels involved as co-variates will be performed. Discussion With an aging population, the prevalence of osteoporosis and related complications such as vertebral compression fractures is expected to increase. Therefore, there is a growing need for evidence-based fracture treatments. This study fills a gap in the evidence base for treatment of painful osteoporotic vertebral fractures and will likely influence future treatment guidelines. Trial registration The study has been evaluated and approved by the Regional Committees on Health Research for Southern Denmark October 9 2023 (Projekt-ID S-20230058) and the Danish Data Protection Agency 23/40,938. The protocol has been registered at ClinicalTrials.gov with trial registration number NCT06141187 November 21, 2023.

Abstract Background Lumbar spinal stenosis (LSS) is the most common reason for spine surgery in older people. However, surgery rates vary widely both internationally and nationally. This study compared patient and sociodemographic characteristics, geographical location and comorbidity between surgically and non-surgically treated Danish patients diagnosed with LSS from 2002 to 2018 and described variations over time. Methods Diagnostic ICD-10 codes identifying patients with LSS and surgical procedure codes for decompression with or without fusion were retrieved from the Danish National Patient Register. Patients ≥ 18 years who had been admitted to private or public hospitals in Denmark between 2002 and 2018 were included. Data on age, sex, income, retirement status, geographical region and comorbidity were extracted. A multivariable logistic regression model was used to calculate the relative risk for surgically versus non-surgically treated LSS patients using the total population and subsequently divided into three time periods. Variations over time were displayed graphically. Results A total of 83,783 unique patients with an LSS diagnosis were identified, and of these, 38,362 (46%) underwent decompression surgery. Compared to those who did not receive surgery, the surgically treated patients were more likely to be aged 65–74 years, were less likely to have comorbidities, had higher income and were more likely to reside in the northern part of Denmark. Patients aged 65–74 years remained more likely to receive surgery over time, although the difference between age groups eventually diminished, as older patients (aged ≥ 75) were increasingly more likely to undergo surgery. Large variations and differences in the relative risk of surgery were observed within and between the geographical regions. The likelihood of receiving surgery varied up to threefold between regions. Conclusion Danish patients with LSS who receive surgery differ in a number of respects from those not receiving surgery. Patients aged 65 to 74 years were more likely to receive surgery than other age groups, and LSS surgical patients were healthier, more often retired and had higher incomes than those not undergoing surgery. There were considerable variations in the relative risk of surgery between and within geographical regions.