Department of Orthopedics and Traumatology, Turku University Hospital and University of Turku, Turku, Finland
Department of Orthopedics and Traumatology, Turku University Hospital and University of Turku, Turku, Finland.
BMJ Open. 2022 Jan 31;12(1):e055097. doi: 10.1136/bmjopen-2021-055097.
The incidence of olecranon fractures is growing in the elderly population. The traditional operative approach is giving way among the elderly to conservative treatment, which seems to provide a comparable functional outcome with a lower complication burden. However, there is still a lack of reliable evidence to support this shift.The objective of this trial is to investigate whether conservative treatment of displaced olecranon fractures in patients aged 75 or older yields comparable results to those of operative treatment in terms of pain and daily function.
Scandinavian Olecranon Research in the Elderly (SCORE) is a randomised, controlled, multicentre, non-inferiority trial. Eligible patients will be randomised to either conservative or operative treatment. The sample size will be 68 patients and allocation done at a 1:1 ratio (34 patients per group). The randomisation is stratified according to the participating hospital and patient's sex. Both groups will receive the same postoperative physiotherapy and pain management. The primary outcome is Disabilities of the Arm, Shoulder and Hand at 1-year follow-up. Secondary outcomes are pain and satisfaction measured on visual analogue scales, Patient Reported Elbow Evaluation, range of motion of the elbow and extension strength of the elbow compared with the unaffected arm. Radiographs will be taken at each follow-up. Primary analysis of the results will be conducted on an intention-to-treat basis.
The study protocol for this clinical trial has been approved by the Ethics Committee of the Hospital District of Southwest Finland and will be submitted for approval to the Regional Ethics Committees in Linköping, Sweden and Copenhagen, Denmark. Every recruiting centre will apply local research approvals. The results of this study will be submitted for publication in peer-reviewed journals.
NCT04401462.
This is the second protocol version dated on 16 April 2020.
在老年人群中，尺骨鹰嘴骨折的发病率正在上升。传统的手术方法在老年人中逐渐被保守治疗所取代，保守治疗似乎能提供与更低并发症负担相当的功能结果。然而，目前仍然缺乏可靠的证据来支持这种转变。本试验的目的是研究对于 75 岁或以上的移位尺骨鹰嘴骨折患者，保守治疗是否能在疼痛和日常功能方面与手术治疗取得可比的结果。
斯堪的纳维亚老年尺骨鹰嘴研究（SCORE）是一项随机、对照、多中心、非劣效性试验。符合条件的患者将被随机分配到保守治疗或手术治疗组。样本量为 68 例，分配比例为 1:1（每组 34 例）。随机分组按参与医院和患者性别分层。两组都将接受相同的术后物理治疗和疼痛管理。主要结局是 1 年随访时的上肢功能障碍问卷。次要结局是通过视觉模拟量表、患者报告的肘部评估、肘关节活动度和与未受伤手臂相比的肘关节伸展力量来测量疼痛和满意度。每次随访都将拍摄 X 光片。结果的主要分析将基于意向治疗进行。
本临床试验的研究方案已获得芬兰西南部地区医院区伦理委员会的批准，并将提交瑞典林雪平地区伦理委员会和丹麦哥本哈根地区伦理委员会批准。每个招募中心都将申请当地的研究批准。本研究的结果将提交给同行评审期刊发表。
NCT04401462。
这是 2020 年 4 月 16 日的第二版方案。
