RESUMEN
Aims: Scoliosis is a lateral curvature of the spine with associated rotation, often causing distress due to appearance. For some curves, there is good evidence to support the use of a spinal brace, worn for 20 to 24 hours a day to minimize the curve, making it as straight as possible during growth, preventing progression. Compliance can be poor due to appearance and comfort. A night-time brace, worn for eight to 12 hours, can achieve higher levels of curve correction while patients are supine, and could be preferable for patients, but evidence of efficacy is limited. This is the protocol for a randomized controlled trial of 'full-time bracing' versus 'night-time bracing' in adolescent idiopathic scoliosis (AIS). Methods: UK paediatric spine clinics will recruit 780 participants aged ten to 15 years-old with AIS, Risser stage 0, 1, or 2, and curve size (Cobb angle) 20° to 40° with apex at or below T7. Patients are randomly allocated 1:1, to either full-time or night-time bracing. A qualitative sub-study will explore communication and experiences of families in terms of bracing and research. Patient and Public Involvement & Engagement informed study design and will assist with aspects of trial delivery and dissemination. Discussion: The primary outcome is 'treatment failure' (Cobb angle progression to 50° or more before skeletal maturity); skeletal maturity is at Risser stage 4 in females and 5 in males, or 'treatment success' (Cobb angle less than 50° at skeletal maturity). The comparison is on a non-inferiority basis (non-inferiority margin 11%). Participants are followed up every six months while in brace, and at one and two years after skeletal maturity. Secondary outcomes include the Scoliosis Research Society 22 questionnaire and measures of quality of life, psychological effects of bracing, adherence, anxiety and depression, sleep, satisfaction, and educational attainment. All data will be collected through the British Spine Registry.
RESUMEN
BACKGROUND AND OBJECTIVES: The Toronto extremity salvage score (TESS) assesses physical function following limb salvage for bone and soft tissue sarcoma. In 2012, Clayer et al. showed increasing age affects the TESS score in normal individuals. The purpose of this study was to investigate what other patient factors affect outcome? METHODS: We reviewed the TESS scores, age, sex, BMI, diagnosis, smoking status, and social deprivation score of patients who have undergone limb salvage in our unit. Data were extracted from our tumor database and reviewed. Statistical analysis was performed using Wilcoxon pairwise test and linear regression analysis. RESULTS: Four hundred and ninety-eight TESS scores were found for 198 patients. Data were analyzed separating upper limb (UL) and lower limb (LL) tumors. In the UL group, being female (P = 0.01) and having a bone lesion (P < 0.001) were associated with a lower TESS score. In the LL group, being female (P = 0.04), increasing age (P = 0.002), having a bone lesion (P < 0.001), increasing BMI (P < 0.001), and smoking (P = 0.005) were associated with a lower TESS score. CONCLUSIONS: Analysis has shown that female sex, increasing age and BMI, smoking and having a bone lesion have an adverse effect on physical function following limb salvage, as indicated by the mean TESS score. J. Surg. Oncol. 2016;113:804-810. © 2016 Wiley Periodicals, Inc.
