Blixt Simon, Mukka Sebastian, Försth Peter, Westin Olof, Gerdhem Paul
Department of Clinical Science Intervention and Technology, Karolinska Institutet, K54, Stockholm; Department of Reconstructive Orthopaedics, Karolinska University Hospital, Huddinge, Stockholm.
Department of Surgical and Perioperative Sciences (Orthopaedics), Umeå University, Umeå.
Acta Orthop. 2022 Jan 24;93:256-263. doi: 10.2340/17453674.2022.1614.
The treatment for patients with thoracolumbar burst fractures without neurological deficit or complete rupture of the posterior ligament complex (PLC) is controversial and includes both surgical and non-surgical options. Current evidence on which treatment is optimal remains inconclusive. In this study we compare surgical with non-surgical treatment.
The study is a nationwide, multicenter, register-based randomized controlled trial (R-RCT). Patients with a thoracolumbar burst fracture will be identified by the Swedish Fracture Register. The admitting physician will be notified during the registration process and the patient will be screened for eligibility. Patients, 18 to 66 years old without neurologic deficit to more than a single nerve root and without complete rupture of the PLC, are eligible for the study. 202 patients will be randomized in a 1:1 relation to either surgical or non-surgical treatment. Patient-reported outcome measures (PROMs), including the Oswestry Disability Index (ODI) and radiological data, will be collected at the time of injury, after 3-4 months, and after 1 year. Additional data from national health registries will be collected after 1 year.
The primary outcome is the ODI 1 year after injury. Secondary outcomes include additional PROMs, adverse events, drug consumption, sick leave, healthcare consumption, and imaging data.
The primary outcome is the ODI 1 year after injury. Secondary outcomes include additional PROMs, adverse events, drug consumption, sick leave, healthcare consumption, and imaging data. Estimated duration - The study started on September 1, 2021 and will continue for approximately 4 years. Trial registration - The trial is registered at www.clinicaltrials.com, NCT05003180.
对于无神经功能缺损或后韧带复合体（PLC）未完全断裂的胸腰椎爆裂骨折患者，治疗方法存在争议，包括手术和非手术选择。目前关于哪种治疗方法最佳的证据尚无定论。在本研究中，我们比较手术治疗与非手术治疗。
本研究是一项全国性、多中心、基于登记的随机对照试验（R-RCT）。胸腰椎爆裂骨折患者将通过瑞典骨折登记处进行识别。在登记过程中，将通知主治医生，对患者进行资格筛查。年龄在18至66岁之间、无超过单神经根神经功能缺损且PLC未完全断裂的患者符合研究条件。202例患者将按1:1的比例随机分为手术治疗组或非手术治疗组。将在受伤时、3-4个月后和1年后收集患者报告的结局指标（PROMs），包括奥斯威斯利功能障碍指数（ODI）和放射学数据。1年后将从国家健康登记处收集额外数据。
主要结局是受伤1年后的ODI。次要结局包括其他PROMs、不良事件、药物消耗、病假、医疗保健消耗和影像学数据。
主要结局是受伤1年后的ODI。次要结局包括其他PROMs、不良事件、药物消耗、病假、医疗保健消耗和影像学数据。预计持续时间 - 本研究于2021年9月1日开始，将持续约4年。试验注册 - 该试验已在www.clinicaltrials.com注册，NCT05003180。
