北欧创新性治疗骨质疏松性骨折试验协作组（NITEP）：前瞻性、随机对照试验——“北欧 DeltaCon 试验方案：对于 65 岁及以上伴有移位的肱骨近端骨折患者，采用非手术治疗与反式全肩关节置换术的对比”。
Nordic Innovative Trials to Evaluate osteoPorotic Fractures (NITEP) Collaboration: The Nordic DeltaCon Trial protocol-non-operative treatment versus reversed total shoulder arthroplasty in patients 65 years of age and older with a displaced proximal humerus fracture: a prospective, randomised controlled trial.
机构信息
Tampere University Hospital, Tampere, Finland.
Oslo University Hospital, Oslo, Norway.
出版信息
BMJ Open. 2019 Jan 29;9(1):e024916. doi: 10.1136/bmjopen-2018-024916.
INTRODUCTION
The proximal humerus fracture (PHF) is one of the most common fractures in the elderly. The majority of PHFs are treated non-operatively, while 15%-33% of patients undergo surgical treatment. Recent randomised controlled trial (RCT) and meta-analyses have shown that there is no difference in outcome between non-operative treatment and locking plate or hemi-arthroplasty. During the past decade, reverse total shoulder arthroplasty (RTSA) has gained popularity in the treatment of PHF, although there is a lack of RCTs comparing RTSA to non-operative treatment.
METHODS
This is a prospective, single-blinded, randomised, controlled, multicentre and multinational trial comparing RTSA with non-operative treatment in displaced proximal humeral fractures in patients 65-85 years. The primary outcome in this study is QuickDASH-score measured at 2 years. Secondary outcomes include visual analogue scale for pain, grip strength, Oxford shoulder score, Constant score and the number of reoperations and complications.The hypothesis of the trial is that operative treatment with RTSA produces better outcome after 2 and 5 years measured with QuickDASH.
ETHICS AND DISSEMINATION
In this protocol, we describe the design, method and management of the Nordic DeltaCon trial. The ethical approval for the trial has been given by the Regional Committee for Medical and Health Research Ethics, Norway. There have been several examples in orthopaedics of innovations that result in failure after medium-term follow-ups . In order to prevent such failures and to increase our knowledge of RSTA, we feel a large-scale study of the effects of the surgery on the outcome that focuses on the complications and reoperations is warranted. After the trial 2-year follow-up, the results will be disseminated in a major orthopaedic publication.
TRIAL REGISTRATION NUMBER
NCT03531463; Pre-Results.
简介
肱骨近端骨折（PHF）是老年人中最常见的骨折之一。大多数 PHF 采用非手术治疗，而 15%-33%的患者接受手术治疗。最近的随机对照试验（RCT）和荟萃分析表明，非手术治疗与锁定钢板或半关节成形术之间的结果没有差异。在过去的十年中，反向全肩关节置换术（RTSA）在 PHF 的治疗中越来越受欢迎，尽管缺乏 RCT 比较 RTSA 与非手术治疗。
方法
这是一项前瞻性、单盲、随机、对照、多中心和多国家试验，比较 RTSA 与非手术治疗 65-85 岁移位性肱骨近端骨折患者。本研究的主要结局是 2 年时的 QuickDASH 评分。次要结局包括疼痛的视觉模拟评分、握力、牛津肩评分、Constant 评分以及再次手术和并发症的数量。试验的假设是，与非手术治疗相比，RTSA 治疗后 2 年和 5 年的 QuickDASH 结果更好。
伦理和传播
在本方案中，我们描述了 Nordic DeltaCon 试验的设计、方法和管理。该试验的伦理批准已获得挪威区域医学和健康研究伦理委员会的批准。在矫形外科领域，有几个创新的例子在中期随访后导致失败。为了防止这种失败，并增加我们对 RSTA 的了解，我们认为有必要进行一项大规模的研究，以关注手术对并发症和再次手术的影响，从而评估手术的效果。试验 2 年随访后，结果将在主要的矫形外科出版物中公布。
试验注册号
NCT03531463；预结果。
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