Department of Orthopedic Surgery, Kolding Hospital, Kolding, Denmark.
Department of Orthopedic Surgery, Centre for Evidence-Based Orthopaedics, Zealand University Hospital, Køge, Denmark.
Trials. 2022 Jun 2;23(1):453. doi: 10.1186/s13063-022-06317-6.
The outcome of non-surgical treatment is generally good, but the treatment course can be long and painful with approximately a quarter of the patients acquiring a nonunion. Both surgical and non-surgical treatment can have disabling consequences such as nerve injury, infection, and nonunion. The purpose of the study is to compare patient-reported outcomes after surgical and non-surgical treatment for humeral shaft fractures.
A pragmatic randomized controlled trial (RCT) is planned with two study groups (SHAFT-Young and SHAFT-Elderly). A total of 287 eligible acute humeral shaft fractures are scheduled to be recruited and randomly allocated to surgical or non-surgical treatment with the option of early crossover due to delayed union. The surgical method within the allocation is decided by the surgeon. The primary outcome is the Disability of Arm, Shoulder, and Hand (DASH) score at 52 weeks, and is assessor blinded. The secondary outcomes are DASH score, EQ-5D-5L, pain assessed by visual analog score, Constant-Murley score including elbow range of motion, and anchor questions collected at all timepoints throughout the trial. All complications will be reported including; infection, nerve or vascular injury, surgical revisions (implant malpositioning, hardware failure, aseptic loosening, and peri-implant fracture), major adverse cardiovascular events, and mortality.
The SHAFT trial is a pragmatic multicenter RCT, that will compare the effectiveness of the main strategies in humeral shaft fracture treatment. This will include a variety of fracture morphologies, while taking the dilemmas within the population into account by splitting the population by age and providing the orthopedic society with an interval for early crossover surgery.
Clinicaltrials.gov NCT04574336 . Registered on 5 October 2020.
非手术治疗的结果通常较好，但治疗过程可能漫长而痛苦，约有四分之一的患者会出现骨折不愈合。手术和非手术治疗都可能导致神经损伤、感染和骨折不愈合等致残后果。本研究旨在比较肱骨干骨折手术和非手术治疗后的患者报告结局。
计划进行一项实用随机对照试验（RCT），分为两组（SHAFT-Young 和 SHAFT-Elderly）。共计划招募 287 例符合条件的急性肱骨干骨折患者，并随机分配至手术或非手术治疗，对于延迟愈合的患者可选择早期交叉。分配内的手术方法由外科医生决定。主要结局是 52 周时的手臂、肩部和手部残疾（DASH）评分，采用评估者盲法评估。次要结局包括 DASH 评分、EQ-5D-5L、视觉模拟评分评估的疼痛、Constant-Murley 评分（包括肘活动范围）和试验过程中所有时间点收集的锚定问题。所有并发症均报告，包括感染、神经或血管损伤、手术修正（植入物位置不当、器械失效、无菌性松动和植入物周围骨折）、主要不良心血管事件和死亡率。
SHAFT 试验是一项实用的多中心 RCT，将比较肱骨干骨折治疗主要策略的有效性。这将包括各种骨折形态，同时通过按年龄分组考虑人群中的困境，并为骨科协会提供早期交叉手术的间隔，为人群提供了便利。
Clinicaltrials.gov NCT04574336。于 2020 年 10 月 5 日注册。
