Objective This study aimed to compare the efficacy and safety of romosozumab, a bone anabolic agent, versus vertebroplasty, a conventional surgical intervention, in treating osteoporotic vertebral compression fractures (OVCFs).
Methods A retrospective analysis included 86 thoracic/lumbar compression fracture patients from 2014 to 2022 at a medical center. Forty-two patients received romosozumab (monthly injections for 1 year) followed by 1 year of denosumab, while 44 underwent vertebroplasty followed by denosumab injections biannually for 2 years. Outcomes were assessed using the Numerical Rating Scale (NRS) for pain, bone mineral density (BMD), vertebral compression ratio, and Cobb angle over 12 months.
Results At 12 months, the romosozumab group showed a greater reduction in NRS scores (4.90 ± 1.01 vs. 4.27 ± 1.34, p = 0.015) and a higher increase in lumbar BMD (0.8 ± 0.5 vs. 0.5 ± 0.3, p = 0.000) compared to the vertebroplasty group. There were no significant differences in changes in hip total BMD and femur neck BMD (p = 0.190, p = 0.167, respectively). Radiographic assessments showed no significant differences in vertebral compression ratio (14.7% vs. 14.8%; p = 0.960) or Cobb angle (4.2° vs. 4.9°; p = 0.302). The incidence of major osteoporotic fractures was lower in the romosozumab group (7.1% vs. 25.0%, p = 0.051), with similar rates of cardiovascular events in both groups (4.8% vs. 9.1%, p = 0.716).
Conclusion Romosozumab has demonstrated superior pain reduction and lumbar BMD improvement compared to vertebroplasty at 12 months, with no significant differences in radiographic outcomes or adverse events, suggesting it as an alternative to vertebroplasty for OVCF.
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Objective To compare the safety profiles of biportal endoscopic spinal surgery (BESS) and microscopic spinal surgery (MSS) for lumbar disc herniation and spinal stenosis by analyzing the associated adverse events.
Methods We pooled data from 2 prospective randomized controlled trials involving 220 patients (110 in each group) who underwent single-level lumbar surgery. Participants aged 20–80 years with radiating pain due to lumbar disc herniation or spinal stenosis were included in this study. Adverse events were recorded and analyzed over a 12-month follow-up period.
Results The overall adverse event rates were 9.1% (10 of 110) in the BESS group and 17.3% (19 of 110) in the MSS group, which were not statistically significantly different (p=0.133). Notably, wound dehiscence occurred in 8.2% of MSS cases but in none of the BESS cases. Both groups showed similarly low rates of complications, such as dural tears, epidural hematoma, and nerve root injury. The most common adverse event in the BESS group was recurrent disc herniation (2.7%), whereas that in the MSS group was wound dehiscence (8.2%).
Conclusion BESS demonstrated a safety profile comparable to that of MSS for the treatment of lumbar disc herniation and spinal stenosis, with a trend towards fewer overall complications. BESS offers particular advantages in terms of reducing wound-related complications. These findings suggest that BESS is a safe alternative to conventional MSS and potentially offers the benefits of a minimally invasive approach without compromising patient safety.
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Objective The reported incidence of complications and/or adverse events (AEs) following spine surgery varies greatly. A validated, systematic, reproducible reporting system to quantify AEs was used in 2 prospective cohorts, from 2 spine surgery centers, conducting either complex or purely degenerative spine surgery; in a comparative fashion. The aim was to highlight the differences between 2 distinctly different prospective cohorts with patients from the same background population.
Methods AEs were registered according to the predefined AE variables in the SAVES (Spine AdVerse Events Severity) system which was used to record all intra- and perioperative AEs. Additional outcomes, including mortality, length of stay, wound infection requiring revision, readmission, and unplanned revision surgery during the index admission, were also registered.
Results A total of 593 complex and 1,687 degenerative procedures were consecutively included with 100% data completion. There was a significant difference in morbidity when comparing the total number of AEs between the 2 groups (p < 0.001): with a mean number of 1.42 AEs per patient (n = 845) in the complex cohort, and 0.97 AEs per patient (n = 1,630) in the degenerative cohort.
Conclusion In this prospective study comparing 2 cohorts, we report the rates of AEs related to spine surgery using a validated reproducible grading system for registration. The rates of morbidity and mortality were significantly higher following complex spine surgery compared to surgery for degenerative spine disease.
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