Department of Neurosurgery, Leiden University Medical Centre, PO Box 9600, 2300 RC Leiden, The Netherlands.
BMC Musculoskelet Disord. 2014 Jan 8;15:7. doi: 10.1186/1471-2474-15-7.
Fractures of the odontoid process of the axis are the most common fractures of the geriatric cervical spine. As the population ages, their incidence is expected to increase progressively, as is the number of very old patients (>80 years) with an odontoid fracture. No consensus exists on the optimal treatment (surgical or conservative) and the most relevant outcome parameter (osseous union, fracture stability or clinical outcome). The aim of the INNOVATE (INterNational study on Odontoid frActure Treatment in the Elderly) Trial is to prospectively assess fracture healing and clinical outcome after surgical and conservative treatment for odontoid fractures in the elderly patient, with a specific focus on the very old patient.
METHODS/DESIGN: The trial is an observational study in which eleven centres in five European countries are involved. All patients admitted to one of these centres who meet the selection criteria (≥55 years, acute (<two weeks) type II/III odontoid fracture, no rheumatoid arthritis, no ankylosing spondylitis, no previous treatment for odontoid fracture) are asked to participate. The applied treatment is in accordance with usual care and chosen by the treating surgeon and patient. A cohort of 275 patients will be included. Clinical and radiological follow-up moments are scheduled at 6, 12, 26, 52 and 104 weeks, at which both surgeon and patient will complete Case Record Forms (CRFs). The primary outcome will be a combination of fracture healing and clinical outcome at 52 weeks. Osseous union and fracture stability will be assessed with CT-imaging and dynamic X-ray. Clinical outcome will be scored by the Neck Disability Index (NDI) and correlated to the imaging data. Additionally, predefined subgroup analysis will be carried out (i.e. for patient age and osteoporosis) and prognostic factors will be identified.
Evidence for the optimal treatment for odontoid fractures is lacking. Focusing on both fracture healing and clinical outcome, the results of this study will yield valuable information enabling more rational decision making in the treatment for odontoid fractures in the elderly.
Netherlands Trial Register NTR3630.
枢椎齿状突骨折是老年颈椎最常见的骨折。随着人口老龄化，其发病率预计将逐步增加，伴有齿状突骨折的非常老年患者（>80 岁）的数量也将增加。对于最佳治疗方法（手术或保守治疗）以及最相关的结果参数（骨愈合、骨折稳定性或临床结果）尚未达成共识。INNOVATE（老年人齿状突骨折治疗国际研究）试验的目的是前瞻性评估老年患者手术和保守治疗齿状突骨折后的骨折愈合和临床结果，特别关注非常老年患者。
方法/设计：该试验是一项观察性研究，涉及五个欧洲国家的十一个中心。所有符合入选标准（≥55 岁、急性（<2 周）Ⅱ/Ⅲ型齿状突骨折、无类风湿关节炎、无强直性脊柱炎、无齿状突骨折既往治疗）的被收入这些中心之一的患者都被要求参与。应用的治疗方法符合常规护理，并由治疗外科医生和患者选择。将纳入 275 例患者的队列。临床和放射学随访时间为 6、12、26、52 和 104 周，届时外科医生和患者将完成病例报告表（CRFs）。主要结果将是 52 周时骨折愈合和临床结果的组合。骨愈合和骨折稳定性将通过 CT 成像和动态 X 射线评估。临床结果将通过颈椎残障指数（NDI）评分，并与影像学数据相关联。此外，还将进行预定的亚组分析（即患者年龄和骨质疏松症）并确定预后因素。
缺乏最佳治疗齿状突骨折的证据。本研究将重点关注骨折愈合和临床结果，其结果将提供有价值的信息，使我们能够在治疗老年人齿状突骨折时做出更合理的决策。
荷兰试验注册 NTR3630。
