Center for Health Technology and Services Research, CINTESIS, Porto, Portugal.
Departamento Medicina da Comunidade, Informação e Decisão em Saúde, MEDCIDS - Faculdade de Medicina da Universidade do Porto, FMUP, Portugal.
Spine (Phila Pa 1976). 2020 Nov 15;45(22):E1523-E1531. doi: 10.1097/BRS.0000000000003655.
Systematic review and meta-analysis of randomized controlled trial (RCT).
The aim of this study was to evaluate radiological and clinical outcomes of acute traumatic thoracolumbar fractures in skeletally mature patients treated with orthosis, versus no immobilization.
Orthosis is traditionally used in conservative treatment of thoracolumbar fractures. However, recent studies suggest no benefit, and a possible negative impact in recovery.
Databases were searched from inception to June 2019. Studies were selected in two phases by two blinded reviewers; disagreements were solved by consensus. Inclusion criteria were: RCT; only patients with acute traumatic thoracolumbar fractures; primary conservative treatment; comparison between orthosis and no orthosis. Exclusion criteria were inclusion of nonacute fractures, patients with other significant known diseases and comparison of groups different than use of an orthosis. Two independent reviewers performed data extraction and quality assessment. Fixed-effects models were used upon no heterogeneity, and random-effects model in the remaining cases. A previous plan for extraction of radiological (kyphosis progression; loss of anterior height) and clinical (pain; disability; length of stay) outcomes was applied. PRISMA guidelines were followed.
Eight articles/five studies were included (267 participants). None reported significant differences in pain, kyphosis progression, and loss of anterior height. One reported a better ODI with orthosis at 12 but not at 24 weeks. No other study reported differences in disability. All authors concluded an equivalence between treatments.Meta-analysis showed a significant increase of 3.47days (95% confidence interval 1.35-5.60) in mean admission time in orthosis group. No differences were found in kyphosis at 6 and 12 months; kyphosis progression between 0 to 6 and 0 to 12 months; loss of anterior height 0 to 6 months; VAS for pain at 6 months; VAS change 0 to 6 months.
Orthosis seems to add no benefit in conservative treatment of acute thoracolumbar fractures. This should be considered in guidelines and reviews of health care policies.
系统评价和随机对照试验（RCT）的荟萃分析。
本研究旨在评估在成熟骨骼患者中，急性创伤性胸腰椎骨折使用矫形器与不固定治疗的影像学和临床结果。
矫形器传统上用于胸腰椎骨折的保守治疗。然而，最近的研究表明其没有益处，并且可能对恢复产生负面影响。
从开始到 2019 年 6 月，我们在数据库中进行了搜索。两名盲审员分两个阶段对研究进行选择；有分歧的地方通过共识解决。纳入标准为：RCT；仅急性创伤性胸腰椎骨折患者；主要保守治疗；矫形器与不使用矫形器的比较。排除标准为包括非急性骨折、其他明显已知疾病的患者以及比较组不同于使用矫形器的患者。两名独立的评审员进行了数据提取和质量评估。在无异质性的情况下使用固定效应模型，在其余情况下使用随机效应模型。应用了先前制定的影像学（后凸进展；前高丢失）和临床（疼痛；残疾；住院时间）结局的提取计划。遵循 PRISMA 指南。
纳入了 8 篇文章/5 项研究（267 名参与者）。没有一项研究报告疼痛、后凸进展和前高丢失方面有显著差异。有一项研究报告称，矫形器在 12 周时的 ODI 更好，但在 24 周时则不然。其他研究均未报告残疾方面的差异。所有作者都认为两种治疗方法等效。荟萃分析显示，矫形器组的平均住院时间平均增加了 3.47 天（95%置信区间为 1.35-5.60）。在 6 个月和 12 个月时，后凸无差异；0 至 6 个月和 0 至 12 个月之间的后凸进展无差异；0 至 6 个月时的前高丢失无差异；6 个月时的 VAS 疼痛评分无差异；0 至 6 个月时的 VAS 变化无差异。
在急性胸腰椎骨折的保守治疗中，矫形器似乎没有益处。这应该在指南和医疗保健政策的审查中考虑。
3。
