多中心随机对照临床试验中肱骨近端骨折的外部有效性：DelPhi 试验。

External validity in a multicenter randomized clinical trial of proximal humeral fractures: the DelPhi trial.

机构信息

Division of Surgery, Orthopaedic Department, Oslo University Hospital, Ullevål, Norway.

Department of Orthopedic Surgery, Østfold Hospital Trust, Grålum, Norway.

出版信息

Eur J Orthop Surg Traumatol. 2022 Feb;32(2):317-323. doi: 10.1007/s00590-021-02982-6. Epub 2021 Apr 20.

DOI:10.1007/s00590-021-02982-6

PMID:33880653

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8783856/

Abstract

BACKGROUND

Randomized controlled trials (RCT) are regarded as the gold standard for effect evaluation in clinical interventions. However, RCTs may not produce relevant results to all patient groups. We aimed to assess the external validity of a multicenter RCT (DelPhi trial).

METHODS

The DelPhi RCT investigated whether elderly patients with displaced proximal humeral fractures (PHFs) receiving reversed total shoulder prosthetic replacement (RTSA) gained better functional outcomes compared to open reduction and internal fixation (ORIF) using an proximal humerus locking plate (PHILOS). Eligible patients were between 65 and 85 years old with severely displaced 11-B2 or 11-C2 fractures (AO/OTA-classification, 2007). We compared baseline and follow-up data of patients for two of the seven hospitals that were included in the DelPhi trial (n = 54) with non-included patients (n = 69). Comparisons were made based on reviewing medical records regarding demographic, health and fracture parameters.

RESULTS

Forty-four percent of the eligible patients were included in the DelPhi trial. Comparing included and non-included patients indicated higher incidences of serious heart disease (P = 0.044) and a tendency toward higher tobacco intake (P = 0.067) in non-included patients. Furthermore, non-included patients were older (P = 0.040) and had higher ASA classification (P < 0.001) and were in more need for resident aid (in-home assistance) (P = 0.022) than included patients. The cause of PHF was more frequently related to fall indoors in non-included vs. included patients (P = 0.018) and non-included patients were more prone to other concomitant fractures (P = 0.004). Having concomitant fractures was associated with osteoporosis (P = 0.014). We observed no significant differences in rates of complications or deaths between included and non-included patients within 3 months after treatment. In descending order, non-included patients were treated conservatively, with PHILOS, RTSA, anatomic hemi-prothesis or an alternative type of ORIF. RTSA was the preferred treatment choice for C2-type fractures (P < 0.001).

CONCLUSIONS

Results from the DelPhi RCT may not directly apply to older PHFs patients with lower health status or concomitant fractures.

LEVEL OF EVIDENCE

Level 4.

摘要

背景

随机对照试验（RCT）被认为是临床干预效果评估的金标准。然而，RCT 可能无法为所有患者群体产生相关结果。我们旨在评估一项多中心 RCT（DelPhi 试验）的外部有效性。

方法

DelPhi RCT 研究了接受反式全肩关节假体置换术（RTSA）治疗的老年移位肱骨近端骨折（PHF）患者与使用肱骨近端锁定钢板（PHILOS）行切开复位内固定术（ORIF）的患者相比，功能结局是否更好。符合条件的患者年龄在 65 至 85 岁之间，有严重移位的 11-B2 或 11-C2 骨折（AO/OTA 分类，2007 年）。我们比较了 DelPhi 试验中纳入的 7 家医院中的 2 家（n=54）和未纳入的患者（n=69）的基线和随访数据。比较基于查看病历中有关人口统计学、健康和骨折参数的信息。

结果

44%的符合条件的患者被纳入 DelPhi 试验。比较纳入和未纳入的患者，未纳入患者中严重心脏病的发生率更高（P=0.044），且有吸烟倾向（P=0.067）。此外，未纳入患者年龄更大（P=0.040），ASA 分级更高（P<0.001），更需要居民援助（家庭援助）（P=0.022）。PHF 的病因在未纳入患者中更常与室内跌倒有关（P=0.018），且未纳入患者更易发生其他伴发骨折（P=0.004）。伴发骨折与骨质疏松症有关（P=0.014）。我们观察到治疗后 3 个月内，纳入和未纳入患者的并发症或死亡率之间无显著差异。按降序排列，未纳入患者接受保守治疗、PHILOS、RTSA、解剖半假体或其他类型的 ORIF。对于 C2 型骨折，RTSA 是首选治疗方法（P<0.001）。