Centre for Rehabilitation Sciences, Health Sciences and Social Care Institute, Teesside University, Middlesbrough, Tees Valley TS1 3BA, UK.
BMC Musculoskelet Disord. 2009 Nov 16;10:140. doi: 10.1186/1471-2474-10-140.
Proximal humeral fractures, which occur mainly in older adults, account for approximately 4 to 5% of all fractures. Approximately 40% of these fractures are displaced fractures involving the surgical neck. Management of this group of fractures is often challenging and the outcome is frequently unsatisfactory. In particular it is not clear whether surgery gives better outcomes than non-surgical management. Currently there is much variation in the use of surgery and a lack of good quality evidence to inform this decision.
METHODS/DESIGN: We aim to undertake a pragmatic UK-based multi-centre randomised controlled trial evaluating the effectiveness and cost-effectiveness of surgical versus standard non-surgical treatment for adults with an acute closed displaced fracture of the proximal humerus with involvement of the surgical neck. The choice of surgical intervention is left to the surgeon, who must use techniques that they are fully experienced with. This will avoid 'learning curve' problems. We will promote good standards of non-surgical care, similarly insisting on care-provider competence, and emphasize the need for comparable provision of rehabilitation for both groups of patients.We aim to recruit 250 patients from a minimum of 18 NHS trauma centres throughout the UK. These patients will be followed-up for 2 years. The primary outcome is the Oxford Shoulder Score, which will be collected via questionnaires completed by the trial participants at 6, 12 and 24 months. This is a 12-item condition-specific questionnaire providing a total score based on the person's subjective assessment of pain and activities of daily living impairment. We will also collect data for other outcomes, including general health measures and complications, and for an economic evaluation. Additionally, we plan a systematic collection of reasons for non-inclusion of eligible patients who were not recruited into the trial, and their baseline characteristics, treatment preferences and intended treatment.
This article presents the protocol for a multi-centre randomised controlled trial. It gives extensive details of, and the basis for, the chosen methods, and describes the key measures taken to avoid bias and to ensure validity.
Current Controlled Trials ISRCTN50850043.
肱骨近端骨折主要发生于老年人，约占所有骨折的 4%至 5%。其中约 40%为涉及外科颈的移位骨折。这类骨折的治疗往往具有挑战性，且治疗效果常常不尽如人意。特别是，手术治疗是否优于非手术治疗尚不清楚。目前，手术的应用存在很大差异，且缺乏高质量的证据来支持这一决策。
方法/设计：我们旨在开展一项基于英国的实用、多中心随机对照试验，评估手术与标准非手术治疗成人急性闭合性移位性肱骨近端骨折伴外科颈受累的有效性和成本效益。手术干预的选择由外科医生决定，外科医生必须使用他们完全熟练掌握的技术。这将避免“学习曲线”问题。我们将促进非手术治疗的良好标准，同样坚持护理人员的能力，强调两组患者都需要进行可比较的康复治疗。我们计划从英国至少 18 家 NHS 创伤中心招募 250 名患者。这些患者将随访 2 年。主要结局指标为牛津肩肘评分，通过试验参与者在 6、12 和 24 个月时完成的问卷进行收集。这是一个 12 项的特定于疾病的问卷，根据个人对疼痛和日常生活活动障碍的主观评估提供总分。我们还将收集其他结局数据，包括一般健康指标和并发症，以及进行经济性评估。此外，我们计划系统地收集未纳入试验的合格患者未被招募的原因，以及他们的基线特征、治疗偏好和预期治疗。
本文介绍了一项多中心随机对照试验的方案。它详细介绍了所选方法的依据，并描述了为避免偏倚和确保有效性而采取的关键措施。
当前对照试验 ISRCTN50850043。
