Emergency Medicine, Royal Devon University Healthcare NHS Foundation Trust, Exeter, Devon, UK.
Emergency Department, Barking Havering and Redbridge University Hospitals NHS Trust, Romford, London, UK.
Emerg Med J. 2023 Nov 28;40(12):832-839. doi: 10.1136/emermed-2023-213279.
There is a high rate of surgical fixation of displaced Colles' type distal radial wrist fractures despite fracture manipulation in the ED. Point-of-care ultrasound has been used to guide ED manipulations but its effect on the quality of fracture reduction or subsequent need for surgical fixation is unknown. This study aims to assess the feasibility of conducting a definitive randomised controlled trial to assess the use of ultrasound to guide these fracture manipulations.
We conducted a pragmatic randomised controlled feasibility trial in two EDs in England over a 6-month period (7 October 2019 to 6 April 2020). Adult patients with wrist fractures undergoing manipulation in the ED were randomised 1:1 to ultrasound-guided distal radial fracture manipulation or manipulation with sham ultrasound. The primary outcome for this study was trial recruitment rate. Other measures were recorded to assess potential future definitive trial outcomes and feasibility.
Of 120 patients meeting inclusion criteria, 48 (40%) were recruited and randomised in the two centres, giving overall recruitment rates of 0.3 and 1.8 participants per week at each site, respectively, and 1 participant per week overall. The most common reason that patients were not included was research staff availability. After 6 weeks, six patients in each group (26% intervention, 24% control) had undergone surgical fixation, with 98% data completeness for this potential definitive trial primary outcome. Randomisation, blinding and data collection processes were effective but there were data limitations in the X-ray assessment of fracture positions.
A definitive study of a similar design would be feasible within UK ED practice but organisational factors and research staff availability should be considered when estimating the predicted recruitment rate and required sites. 6-week surgical fixation rate was the most reliable outcome measure.
ClinicalTrials.gov (NCT03868696).
尽管在急诊科可以进行骨折手法复位，但仍有很高的比例会对桡骨远端 Colles 型骨折进行手术固定。床边超声已被用于指导急诊科的手法复位，但对于骨折复位质量或后续手术固定的需求是否有影响仍不清楚。本研究旨在评估进行一项确定性随机对照试验以评估超声引导这些骨折复位的可行性。
我们在英格兰的两家急诊科进行了一项为期 6 个月的实用随机对照可行性试验（2019 年 10 月 7 日至 2020 年 4 月 6 日）。在急诊科接受手法复位的腕部骨折成年患者被随机分为 1:1 组，接受超声引导下桡骨远端骨折复位或假超声引导下复位。本研究的主要结局为试验招募率。还记录了其他措施以评估潜在的未来确定性试验结局和可行性。
在符合纳入标准的 120 名患者中，有 48 名（40%）在两个中心被招募并随机分组，因此，每个中心的总体招募率分别为每周 0.3 和 1.8 名参与者，每周总共有 1 名参与者。患者未被纳入的最常见原因是研究人员的可用性。在 6 周后，每组各有 6 名患者（干预组 26%，对照组 24%）接受了手术固定，对于这一潜在确定性试验的主要结局，有 98%的数据完整性。随机化、盲法和数据收集过程是有效的，但在 X 射线评估骨折位置方面存在数据限制。
在英国急诊科实践中，类似设计的确定性研究是可行的，但在估计预期招募率和所需站点时，应考虑组织因素和研究人员的可用性。6 周时的手术固定率是最可靠的结局测量指标。
ClinicalTrials.gov（NCT03868696）。
